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FDA 510(k) Applications Submitted by CODMAN & SHURTLEFF, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K840003 01/04/1984 DISPOSABLE ICP KIT DIFF. SIZES CODMAN & SHURTLEFF, INC.
K820087 01/13/1982 CODMAN * REUSABLE PERFORATOR CODMAN & SHURTLEFF, INC.
K770389 02/28/1977 LENS SET, MENTOR TRIAL 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.
K770498 03/14/1977 PRESERVE LUBRICANT CODE NO. 43=4035 CODMAN & SHURTLEFF, INC.
K790920 05/09/1979 INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC.
K771026 06/08/1977 HUANG VEIN HOLDER, #21-8011 CODMAN & SHURTLEFF, INC.
K791101 06/13/1979 DISPOSABLE PERFORATORS, JACOBS, HUDSON 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.
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.
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.
K760770 10/04/1976 SOLA COMMIDO LOUPE CODMAN & SHURTLEFF, INC.
K760771 10/04/1976 SOLA SCHULTZE-CROCK OPTHALMOSCOPE CODMAN & SHURTLEFF, INC.
K760961 10/29/1976 OCCLUSION CLIPS 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.
K761095 11/22/1976 VANDERBILT CURETTE CODMAN & SHURTLEFF, INC.
K761096 11/22/1976 VANDERBILT PITUITARY RETRACTOR CODMAN & SHURTLEFF, INC.
K761097 11/22/1976 VANDERBILT BLADE HOLDER CODMAN & SHURTLEFF, INC.
K761161 11/29/1976 67-8006 DARLING-LINTON AORTIC TOURN. CODMAN & SHURTLEFF, INC.
K834477 12/20/1983 DISPOS. SCOTT CANNULAS 16-1054 ETC. CODMAN & SHURTLEFF, INC.
K132281 07/25/2013 REVASC THROMBECTOMY DEVICE 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.
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.
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.
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.
K140080 01/14/2014 ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB CODMAN & SHURTLEFF, INC.
K140307 02/07/2014 ENVOY GUIDING CATHETER CODMAN & SHURTLEFF, INC.
K133625 12/04/2013 AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & CODMAN & SHURTLEFF, INC.
K150319 02/09/2015 MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS 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.
K912456 06/03/1991 SUNDT SLIM-LINE GRAFT CLIPS CODMAN & SHURTLEFF, INC.
K904352 09/24/1990 CODMAN COLLINS RADIOPARENT STERNAL BLADES CODMAN & SHURTLEFF, INC.
K905433 12/04/1990 CODMAN DISPOSABLE SCALP CLIP APPLIER CODMAN & SHURTLEFF, INC.
K910938 03/06/1991 CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) CODMAN & SHURTLEFF, INC.
K904120 09/06/1990 ACCU-FLO* UNITIZED SHUNT CODMAN & SHURTLEFF, INC.
K915581 12/13/1991 CODMAN SOF'WIRE (TM) KIT 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.
K923555 07/17/1992 CODMAN GAAB NEUROENDOSCOPE CODMAN & SHURTLEFF, INC.
K923646 07/21/1992 CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS CODMAN & SHURTLEFF, INC.
K924977 10/01/1992 CODMAN LASER NEUROENDOSCOPE 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.
K880401 01/29/1988 DENVER PERITONEO-VENOUS SHUNT CODMAN & SHURTLEFF, INC.
K880402 01/29/1988 CODMAN SURGICAL PATTIE CODMAN & SHURTLEFF, INC.
K851229 03/26/1985 CODMAN ARTHROSCOPE CODMAN & SHURTLEFF, INC.
K892215 04/03/1989 UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT 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.
K911917 04/30/1991 CODMAN PEDIATRIC HORSESHOE HEADREST CODMAN & SHURTLEFF, INC.
K911918 04/30/1991 SWIVEL HORSESHOE HEADREST 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.
K871978 05/22/1987 CODMAN FLEXIBLE ENDOSCOPE 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.
K914479 10/08/1991 MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER CODMAN & SHURTLEFF, INC.


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