FDA 510(k) Applications Submitted by CODMAN & SHURTLEFF, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K820087 |
01/13/1982 |
CODMAN * REUSABLE PERFORATOR |
CODMAN & SHURTLEFF, INC. |
| K840003 |
01/04/1984 |
DISPOSABLE ICP KIT DIFF. SIZES |
CODMAN & SHURTLEFF, INC. |
| K760961 |
10/29/1976 |
OCCLUSION CLIPS |
CODMAN & SHURTLEFF, INC. |
| K760770 |
10/04/1976 |
SOLA COMMIDO LOUPE |
CODMAN & SHURTLEFF, INC. |
| K760771 |
10/04/1976 |
SOLA SCHULTZE-CROCK OPTHALMOSCOPE |
CODMAN & SHURTLEFF, INC. |
| K761095 |
11/22/1976 |
VANDERBILT CURETTE |
CODMAN & SHURTLEFF, INC. |
| K761097 |
11/22/1976 |
VANDERBILT BLADE HOLDER |
CODMAN & SHURTLEFF, INC. |
| K761096 |
11/22/1976 |
VANDERBILT PITUITARY RETRACTOR |
CODMAN & SHURTLEFF, INC. |
| K761161 |
11/29/1976 |
67-8006 DARLING-LINTON AORTIC TOURN. |
CODMAN & SHURTLEFF, INC. |
| K760974 |
11/03/1976 |
CHARNLEY FEMORAL COMPONENT |
CODMAN & SHURTLEFF, INC. |
| K760976 |
11/03/1976 |
CHARNLEY REVISION SET |
CODMAN & SHURTLEFF, INC. |
| K760977 |
11/03/1976 |
CHARNLEY FEMUR DRILL #1 AND #2 |
CODMAN & SHURTLEFF, INC. |
| K813123 |
11/04/1981 |
EPC FILTER |
CODMAN & SHURTLEFF, INC. |
| K761002 |
11/08/1976 |
CHARNLEY CONGENITAL HIP FEMUR (85-3060) |
CODMAN & SHURTLEFF, INC. |
| K761003 |
11/08/1976 |
CHARNLEY CONGENITAL HIP FEMUR (85-3061) |
CODMAN & SHURTLEFF, INC. |
| K834477 |
12/20/1983 |
DISPOS. SCOTT CANNULAS 16-1054 ETC. |
CODMAN & SHURTLEFF, INC. |
| K770389 |
02/28/1977 |
LENS SET, MENTOR TRIAL |
CODMAN & SHURTLEFF, INC. |
| K770498 |
03/14/1977 |
PRESERVE LUBRICANT CODE NO. 43=4035 |
CODMAN & SHURTLEFF, INC. |
| K840963 |
03/06/1984 |
SD PLUS PATIENT CAT.#78-8010 |
CODMAN & SHURTLEFF, INC. |
| K840964 |
03/06/1984 |
SD PLUS CLINICIAN CAT# 78-8015 |
CODMAN & SHURTLEFF, INC. |
| K790920 |
05/09/1979 |
INTRACRANIAL PRESSURE MONITORING |
CODMAN & SHURTLEFF, INC. |
| K791101 |
06/13/1979 |
DISPOSABLE PERFORATORS, JACOBS, HUDSON |
CODMAN & SHURTLEFF, INC. |
| K771026 |
06/08/1977 |
HUANG VEIN HOLDER, #21-8011 |
CODMAN & SHURTLEFF, INC. |
| K842774 |
07/16/1984 |
CODMAN SUCTION PUNCH-PRODUCT CODES |
CODMAN & SHURTLEFF, INC. |
| K781411 |
08/15/1978 |
CORNEAL CUTTER AND ACCESSORIES |
CODMAN & SHURTLEFF, INC. |
| K781412 |
08/15/1978 |
OSCILLATING KNIFE AND ACCESSORIES |
CODMAN & SHURTLEFF, INC. |
| K781452 |
08/23/1978 |
BAYLOW VISUAL ACUITY TESTER |
CODMAN & SHURTLEFF, INC. |
| K781465 |
08/25/1978 |
MICROSURGICAL KNIVES, 20, 30, 45 |
CODMAN & SHURTLEFF, INC. |
| K791764 |
08/28/1979 |
SCOVILLE-LEWIS ANEURYSM CLIPS |
CODMAN & SHURTLEFF, INC. |
| K791765 |
08/28/1979 |
MASTERSON* ENDOMETRIAL BIOPSY KIT |
CODMAN & SHURTLEFF, INC. |
| K791978 |
09/28/1979 |
SUGITA ANEURYSM CLIPS, APPLIERS & CASE |
CODMAN & SHURTLEFF, INC. |
| K760745 |
09/30/1976 |
YASARGIL SUCTION TUBE - SMALL |
CODMAN & SHURTLEFF, INC. |
| K760746 |
09/30/1976 |
YASARGIL SUCTION TUBE - LARGE |
CODMAN & SHURTLEFF, INC. |
| K760747 |
09/30/1976 |
YASARGIL SUCTION TUBE - MEDIUM |
CODMAN & SHURTLEFF, INC. |
| K802137 |
09/04/1980 |
CHEEK EPIDURAL SCREW |
CODMAN & SHURTLEFF, INC. |
| K802138 |
09/04/1980 |
CHEEK TOOL SET |
CODMAN & SHURTLEFF, INC. |
| K833015 |
09/06/1983 |
BIOPLAR CORD -DISPOSABLE 30-1538 |
CODMAN & SHURTLEFF, INC. |
| K093973 |
12/24/2009 |
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K933894 |
08/10/1993 |
DISPOSABLE PERFORATOR |
CODMAN & SHURTLEFF, INC. |
| K934196 |
08/26/1993 |
CODMAN QUICK SHUNT KIT, CAT. #82-6570 |
CODMAN & SHURTLEFF, INC. |
| K934756 |
10/05/1993 |
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K931281 |
03/09/1993 |
MICRO ENDOSCOPIC ELECTRODE (ME2) |
CODMAN & SHURTLEFF, INC. |
| K053350 |
12/02/2005 |
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS |
CODMAN & SHURTLEFF, INC. |
| K924242 |
08/24/1992 |
DISPOSABLE PERFORATOR |
CODMAN & SHURTLEFF, INC. |
| K120229 |
01/25/2012 |
ENVOY DISTAL ACCESS GUIDING CATHETER |
CODMAN & SHURTLEFF, INC. |
| K112828 |
09/29/2011 |
REVIVE INTERMEDIATE CATHETER (REVIVE IC) |
CODMAN & SHURTLEFF, INC. |
| K924142 |
08/17/1992 |
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT |
CODMAN & SHURTLEFF, INC. |
| K844212 |
10/31/1984 |
STIMTECH SD CLINICIAN 6090 #78-8055 |
CODMAN & SHURTLEFF, INC. |
| K844213 |
10/31/1984 |
STIMTECH SD PATIENT 6089 #78-8050 |
CODMAN & SHURTLEFF, INC. |
| K844553 |
11/21/1984 |
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE |
CODMAN & SHURTLEFF, INC. |
| K855247 |
12/23/1985 |
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER |
CODMAN & SHURTLEFF, INC. |
| K870399 |
02/02/1987 |
SELVERSTONE CLAMP SALIBI CLAMP |
CODMAN & SHURTLEFF, INC. |
| K851487 |
04/15/1985 |
CODMAN DISPOSABLE BIPOLAR CARD |
CODMAN & SHURTLEFF, INC. |
| K901937 |
04/30/1990 |
CODMAN SUCTION PATTIE |
CODMAN & SHURTLEFF, INC. |
| K902257 |
05/21/1990 |
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) |
CODMAN & SHURTLEFF, INC. |
| K902544 |
06/06/1990 |
SUNDT AVM MICRO CLIP |
CODMAN & SHURTLEFF, INC. |
| K872179 |
06/08/1987 |
CODMAN NEUROLASE LASER SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K894756 |
07/27/1989 |
DENVER PERITONEO-VENUS SHUNT |
CODMAN & SHURTLEFF, INC. |
| K853215 |
08/01/1985 |
ACCU-FLO PRESSURE VALVE |
CODMAN & SHURTLEFF, INC. |
| K913987 |
09/05/1991 |
OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID |
CODMAN & SHURTLEFF, INC. |
| K853770 |
09/09/1985 |
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT |
CODMAN & SHURTLEFF, INC. |
| K020667 |
03/01/2002 |
CODMAN HAKIM SHUNT SYSTEMS |
CODMAN & SHURTLEFF, INC. |
| K031123 |
04/14/2003 |
CODMAN BACTISEAL BARIUM STRIPED CATHETERS |
CODMAN & SHURTLEFF, INC. |
| K041518 |
06/07/2004 |
CODMAN DURAFORM DURAL GRAFT IMPLANT |
CODMAN & SHURTLEFF, INC. |
| K023566 |
10/23/2002 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
CODMAN & SHURTLEFF, INC. |
| K071931 |
07/13/2007 |
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 |
CODMAN & SHURTLEFF, INC. |
| K073336 |
11/28/2007 |
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 |
CODMAN & SHURTLEFF, INC. |
| K083895 |
12/29/2008 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
CODMAN & SHURTLEFF, INC. |
| K880570 |
02/10/1988 |
DENVER PLEURO-PERITONEAL SHUNT |
CODMAN & SHURTLEFF, INC. |
| K894778 |
07/27/1989 |
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER |
CODMAN & SHURTLEFF, INC. |
| K992591 |
08/02/1999 |
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS |
CODMAN & SHURTLEFF, INC. |
| K992905 |
08/30/1999 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K002798 |
09/07/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS |
CODMAN & SHURTLEFF, INC. |
| K003322 |
10/24/2000 |
CODMAN BACTISEAL CATHETERS |
CODMAN & SHURTLEFF, INC. |
| K003549 |
11/17/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS |
CODMAN & SHURTLEFF, INC. |
| K900881 |
02/26/1990 |
OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K920979 |
03/02/1992 |
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) |
CODMAN & SHURTLEFF, INC. |
| K905433 |
12/04/1990 |
CODMAN DISPOSABLE SCALP CLIP APPLIER |
CODMAN & SHURTLEFF, INC. |
| K912456 |
06/03/1991 |
SUNDT SLIM-LINE GRAFT CLIPS |
CODMAN & SHURTLEFF, INC. |
| K904352 |
09/24/1990 |
CODMAN COLLINS RADIOPARENT STERNAL BLADES |
CODMAN & SHURTLEFF, INC. |
| K910938 |
03/06/1991 |
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) |
CODMAN & SHURTLEFF, INC. |
| K915581 |
12/13/1991 |
CODMAN SOF'WIRE (TM) KIT |
CODMAN & SHURTLEFF, INC. |
| K904120 |
09/06/1990 |
ACCU-FLO* UNITIZED SHUNT |
CODMAN & SHURTLEFF, INC. |
| K100351 |
02/12/2010 |
NEUROSCOUT STEERABLE GUIDEWIRE |
CODMAN & SHURTLEFF, INC. |
| K121776 |
06/18/2012 |
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE |
CODMAN & SHURTLEFF, INC. |
| K052449 |
09/06/2005 |
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 |
CODMAN & SHURTLEFF, INC. |
| K061568 |
06/06/2006 |
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
CODMAN & SHURTLEFF, INC. |
| K102961 |
10/05/2010 |
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM |
CODMAN & SHURTLEFF, INC. |
| K050739 |
03/21/2005 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
CODMAN & SHURTLEFF, INC. |
| K093184 |
10/09/2009 |
ENVOY GUIDING CATHETERS |
CODMAN & SHURTLEFF, INC. |
| K041296 |
05/14/2004 |
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI |
CODMAN & SHURTLEFF, INC. |
| K013877 |
11/23/2001 |
CODMAN SLIM-LOC SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K122118 |
07/17/2012 |
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K021653 |
05/20/2002 |
CODMAN BACTISEAL EVD CATHETER SET |
CODMAN & SHURTLEFF, INC. |
| K120686 |
03/06/2012 |
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K003564 |
11/20/2000 |
HAKIM PROGRAMMER AND TRANSMITTER |
CODMAN & SHURTLEFF, INC. |
| K033395 |
10/24/2003 |
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 |
CODMAN & SHURTLEFF, INC. |
| K120117 |
01/17/2012 |
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K924977 |
10/01/1992 |
CODMAN LASER NEUROENDOSCOPE |
CODMAN & SHURTLEFF, INC. |
| K923555 |
07/17/1992 |
CODMAN GAAB NEUROENDOSCOPE |
CODMAN & SHURTLEFF, INC. |
| K923646 |
07/21/1992 |
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS |
CODMAN & SHURTLEFF, INC. |
| K091921 |
06/30/2009 |
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP |
CODMAN & SHURTLEFF, INC. |
| K092437 |
08/07/2009 |
CODMAN STERILIZATION CONTAINERS |
CODMAN & SHURTLEFF, INC. |
| K071791 |
07/02/2007 |
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 |
CODMAN & SHURTLEFF, INC. |
| K071776 |
07/02/2007 |
ANEUROPLASTIC, MODEL 43-1290 |
CODMAN & SHURTLEFF, INC. |
| K123560 |
11/19/2012 |
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM |
CODMAN & SHURTLEFF, INC. |
| K926116 |
12/03/1992 |
CODMAN SOFWIRE(TM) KIT |
CODMAN & SHURTLEFF, INC. |
| K923869 |
08/03/1992 |
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K944612 |
09/19/1994 |
ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K090348 |
02/11/2009 |
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET |
CODMAN & SHURTLEFF, INC. |
| K110751 |
03/18/2011 |
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER |
CODMAN & SHURTLEFF, INC. |
| K091346 |
05/07/2009 |
CODMAN HAKIM MICRO II VALVE |
CODMAN & SHURTLEFF, INC. |
| K102589 |
09/09/2010 |
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER |
CODMAN & SHURTLEFF, INC. |
| K953568 |
07/31/1995 |
CODMAN FIDUCIAL MARKER SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K061876 |
07/03/2006 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
CODMAN & SHURTLEFF, INC. |
| K053107 |
11/04/2005 |
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD |
CODMAN & SHURTLEFF, INC. |
| K880402 |
01/29/1988 |
CODMAN SURGICAL PATTIE |
CODMAN & SHURTLEFF, INC. |
| K880401 |
01/29/1988 |
DENVER PERITONEO-VENOUS SHUNT |
CODMAN & SHURTLEFF, INC. |
| K914479 |
10/08/1991 |
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER |
CODMAN & SHURTLEFF, INC. |
| K851229 |
03/26/1985 |
CODMAN ARTHROSCOPE |
CODMAN & SHURTLEFF, INC. |
| K911723 |
04/17/1991 |
CODMAN DISPOSABLE SKULL PINS |
CODMAN & SHURTLEFF, INC. |
| K911772 |
04/19/1991 |
GARDNER PINS (ADULT & CHILD) |
CODMAN & SHURTLEFF, INC. |
| K892215 |
04/03/1989 |
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT |
CODMAN & SHURTLEFF, INC. |
| K911917 |
04/30/1991 |
CODMAN PEDIATRIC HORSESHOE HEADREST |
CODMAN & SHURTLEFF, INC. |
| K911918 |
04/30/1991 |
SWIVEL HORSESHOE HEADREST |
CODMAN & SHURTLEFF, INC. |
| K871978 |
05/22/1987 |
CODMAN FLEXIBLE ENDOSCOPE |
CODMAN & SHURTLEFF, INC. |
| K912005 |
05/06/1991 |
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE |
CODMAN & SHURTLEFF, INC. |
| K912011 |
05/06/1991 |
CODMAN SKULL CLAMP |
CODMAN & SHURTLEFF, INC. |
| K913170 |
07/17/1991 |
CODMAN SKULL CLAMP |
CODMAN & SHURTLEFF, INC. |
| K853066 |
07/19/1985 |
MAYFIELD DISPOSABLE SKULL PINS |
CODMAN & SHURTLEFF, INC. |
| K913233 |
07/22/1991 |
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM |
CODMAN & SHURTLEFF, INC. |
| K883607 |
08/23/1988 |
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER |
CODMAN & SHURTLEFF, INC. |
| K853626 |
08/29/1985 |
CODMAN LASER BACKSTOP |
CODMAN & SHURTLEFF, INC. |
| K853627 |
08/29/1985 |
CODMAN LASER RODS |
CODMAN & SHURTLEFF, INC. |
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