FDA 510(k) Applications Submitted by ETHICON ENDO-SURGERY, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K110385 02/10/2011 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC.
K091322 05/05/2009 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G ETHICON ENDO-SURGERY, INC.
K030411 02/07/2003 PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 ETHICON ENDO-SURGERY, INC.
K030925 03/24/2003 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 ETHICON ENDO-SURGERY, INC.
K023182 09/24/2002 INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS ETHICON ENDO-SURGERY, INC.
K033700 11/25/2003 MAMMOTOME EX HAND HELD SYSTEM ETHICON ENDO-SURGERY, INC.
K062000 07/17/2006 HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH ETHICON ENDO-SURGERY, INC.
K042753 10/04/2004 MAMMOTOME MR BIOPSY SYSTEM ETHICON ENDO-SURGERY, INC.
K990028 01/05/1999 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC.
K983316 09/21/1998 ULTRACISION 5MM INSTRUMENTS ETHICON ENDO-SURGERY, INC.
K010870 03/23/2001 LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 ETHICON ENDO-SURGERY, INC.
K111195 04/28/2011 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS ETHICON ENDO-SURGERY, INC.
K003297 10/20/2000 MAMMOTOME HAND HELD PROBE, MODEL MHH8 ETHICON ENDO-SURGERY, INC.
K020779 03/11/2002 PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS ETHICON ENDO-SURGERY, INC.
K011501 05/16/2001 ENDOPOUCH RETRIEVER ETHICON ENDO-SURGERY, INC.
K013576 10/29/2001 PERICSCOPE, MODEL # PERISC1 ETHICON ENDO-SURGERY, INC.
K013749 11/13/2001 ENDOANCHOR AND OPENANCHOR ETHICON ENDO-SURGERY, INC.
K991030 03/29/1999 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC.
K992612 08/04/1999 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 ETHICON ENDO-SURGERY, INC.
K002398 08/07/2000 ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING ETHICON ENDO-SURGERY, INC.
K983536 10/09/1998 PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS ETHICON ENDO-SURGERY, INC.
K983925 11/05/1998 ENDOPATH ULTRA VERESS NEEDLE ETHICON ENDO-SURGERY, INC.
K060245 01/31/2006 HARMONIC SCALPEL BLADES AND SHEARS ETHICON ENDO-SURGERY, INC.
K020428 02/08/2002 ENDOPATH DILATING TIP TROCAR, MODEL #512XD ETHICON ENDO-SURGERY, INC.
K011538 05/18/2001 ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM ETHICON ENDO-SURGERY, INC.
K032676 08/29/2003 ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR ETHICON ENDO-SURGERY, INC.
K042897 10/20/2004 AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE ETHICON ENDO-SURGERY, INC.
K053056 10/31/2005 HARMONIC SCALPEL BLADES AND SHEARS ETHICON ENDO-SURGERY, INC.
K020276 01/28/2002 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 ETHICON ENDO-SURGERY, INC.
K051002 04/20/2005 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC.
K033269 10/09/2003 ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD ETHICON ENDO-SURGERY, INC.
K013413 10/15/2001 MICROMARK II TISSUE MARKER,MODEL C1535 ETHICON ENDO-SURGERY, INC.
K091824 06/19/2009 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 ETHICON ENDO-SURGERY, INC.
K093896 12/18/2009 ETHICON ENDO SURGERY SLOTTED ANOSCOPE ETHICON ENDO-SURGERY, INC.
K082955 10/03/2008 ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 ETHICON ENDO-SURGERY, INC.
K073046 10/29/2007 ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 ETHICON ENDO-SURGERY, INC.
K073288 11/21/2007 ETHICON ENDO SURGERY ARTICULATING SNARE ETHICON ENDO-SURGERY, INC.
K971475 04/23/1997 SHIELDED SURGICAL TROCAR ETHICON ENDO-SURGERY, INC.
K971738 05/12/1997 ENDOPATH RESPOSABLE TROCAR SYSTEM ETHICON ENDO-SURGERY, INC.
K972578 07/10/1997 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC.
K963760 09/18/1996 NON-SHIELDED SURGICAL TROCAR AND SLEEVE ETHICON ENDO-SURGERY, INC.
K965045 12/17/1996 TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE ETHICON ENDO-SURGERY, INC.
K003953 12/21/2000 INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 ETHICON ENDO-SURGERY, INC.
K984240 11/27/1998 ENDOPATH ENDOSCOPIC INSTRUMENTS ETHICON ENDO-SURGERY, INC.
K003952 12/21/2000 INDIGO LASEROPTIC TREATMENT SYSTEM ETHICON ENDO-SURGERY, INC.
K040038 01/08/2004 CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G ETHICON ENDO-SURGERY, INC.
K030571 02/24/2003 ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER ETHICON ENDO-SURGERY, INC.
K011257 04/24/2001 ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) ETHICON ENDO-SURGERY, INC.
K012128 07/09/2001 PROTECTIV ACUVANCE IV CATHETER SYSTEM ETHICON ENDO-SURGERY, INC.
K021266 04/22/2002 ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 ETHICON ENDO-SURGERY, INC.
K051301 05/19/2005 PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC.
K031147 04/10/2003 OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR ETHICON ENDO-SURGERY, INC.
K051950 07/18/2005 INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 ETHICON ENDO-SURGERY, INC.
K042777 10/06/2004 HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P ETHICON ENDO-SURGERY, INC.
K980099 01/12/1998 ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) ETHICON ENDO-SURGERY, INC.
K141952 07/18/2014 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED ETHICON ENDO-SURGERY, INC.
K013493 10/22/2001 INDIGO OPTIMA LASER SYSTEM ETHICON ENDO-SURGERY, INC.
K971302 04/08/1997 ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE ETHICON ENDO-SURGERY, INC.
K962584 07/01/1996 ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE ETHICON ENDO-SURGERY, INC.
K973139 08/21/1997 ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR ETHICON ENDO-SURGERY, INC.
K980022 01/05/1998 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) ETHICON ENDO-SURGERY, INC.
K980023 01/05/1998 ENDOPATH AND PROXIMATE LINEAR CUTTERS ETHICON ENDO-SURGERY, INC.
K970079 01/09/1997 PROXIMATE DISPOSABLE SKIN STAPLER ETHICON ENDO-SURGERY, INC.
K970720 02/27/1997 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER ETHICON ENDO-SURGERY, INC.
K980815 03/03/1998 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC.
K961390 04/10/1996 ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER ETHICON ENDO-SURGERY, INC.
K972679 07/16/1997 ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) ETHICON ENDO-SURGERY, INC.
K973803 10/06/1997 FLEXVIEW CO2 BLOWER WITH MIST ETHICON ENDO-SURGERY, INC.
K961264 04/02/1996 ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION ETHICON ENDO-SURGERY, INC.
K955120 11/09/1995 HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR ETHICON ENDO-SURGERY, INC.
K962258 06/12/1996 ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP ETHICON ENDO-SURGERY, INC.
K030472 02/12/2003 MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM ETHICON ENDO-SURGERY, INC.
K051036 04/25/2005 HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P ETHICON ENDO-SURGERY, INC.
K091259 04/29/2009 ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS ETHICON ENDO-SURGERY, INC.
K102632 09/13/2010 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER ETHICON ENDO-SURGERY, INC.
K093236 10/15/2009 ETHICON ENDO-SURGERYOPTICAL DILATOR ETHICON ENDO-SURGERY, INC.
K073484 12/11/2007 ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 ETHICON ENDO-SURGERY, INC.
K101520 06/02/2010 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH ETHICON ENDO-SURGERY, INC.
K012176 07/12/2001 ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 ETHICON ENDO-SURGERY, INC.
K002981 09/25/2000 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 ETHICON ENDO-SURGERY, INC.
K990362 02/05/1999 INSTRUMENT, ULTRASONIC, SCALPEL ETHICON ENDO-SURGERY, INC.
K990430 02/11/1999 ULTRACISION HARMONIC SCALPEL HAND PIECE ETHICON ENDO-SURGERY, INC.
K010898 03/26/2001 ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 ETHICON ENDO-SURGERY, INC.
K993054 09/13/1999 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 ETHICON ENDO-SURGERY, INC.
K002906 09/18/2000 ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 ETHICON ENDO-SURGERY, INC.
K994280 12/20/1999 ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 ETHICON ENDO-SURGERY, INC.
K001220 04/17/2000 ENDOPATH SURESEAL REDUCER CAP ETHICON ENDO-SURGERY, INC.
K991980 06/14/1999 MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, ETHICON ENDO-SURGERY, INC.
K992813 08/20/1999 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT ETHICON ENDO-SURGERY, INC.
K091290 05/01/2009 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 ETHICON ENDO-SURGERY, INC.
K061770 06/23/2006 ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM ETHICON ENDO-SURGERY, INC.
K061156 04/26/2006 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS ETHICON ENDO-SURGERY, INC.
K053631 12/29/2005 CONTOUR TRANSTAR CURVED CUTTER STAPLER SET ETHICON ENDO-SURGERY, INC.


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