FDA 510(k) Applications Submitted by ETHICON, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K182873 10/12/2018 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Ethicon, Inc.
K111751 06/22/2011 VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, INC.
K100280 02/01/2010 GYNCARE MORCELLEX TISSUE MORCELLATOR ETHICON, INC.
K061050 04/17/2006 GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R ETHICON, INC.
K070224 01/24/2007 ULTRAPRO PLUG ETHICON, INC.
K061533 06/02/2006 PROCEED VENTRAL PATCH ETHICON, INC.
K071512 06/04/2007 GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC.
K061037 04/14/2006 PDS PLUS ANTIBACTERIAL SUTURE ETHICON, INC.
K163152 11/10/2016 PROLENE Soft Polypropylene Mesh Ethicon, Inc.
K150670 03/16/2015 STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, INC.
K151200 05/05/2015 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, INC.
K181652 06/22/2018 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture Ethicon, Inc.
K152096 07/28/2015 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive Ethicon, Inc.
K152490 09/01/2015 DERMABOND PRINEO Skin Closure System ETHICON, INC.
K133864 12/19/2013 DERMABOND PRINEO SKIN CLOSURE SYSTEM ETHICON, INC.
K963783 09/20/1996 MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE ETHICON, INC.
K192144 08/08/2019 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Ethicon, Inc.
K133356 10/31/2013 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, INC.
K161726 06/22/2016 E-Pack Procedure Kit ETHICON, INC.
K970896 03/11/1997 MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM ETHICON, INC.
K973384 09/08/1997 ETHICON NON-STICK BIPOLAR FORCEPS ETHICON, INC.
K974299 11/17/1997 PANACRYL ETHICON, INC.
K994418 12/29/1999 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) ETHICON, INC.
K980503 02/09/1998 TEMPORARY CARDIAC PACING WIRE ETHICON, INC.
K010722 03/12/2001 PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC.
K001122 04/07/2000 PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH ETHICON, INC.
K981361 04/14/1998 POWERSTAR BIPOLAR SCISSORS ETHICON, INC.
K981579 05/04/1998 ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG ETHICON, INC.
K972412 06/26/1997 PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC.
K973173 08/25/1997 POWERSTAR BIPOLAR SCISSORS ETHICON, INC.
K003070 10/02/2000 ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, INC.
K974098 10/30/1997 PUBOUURETHRAL SLING ETHICON, INC.
K993801 11/09/1999 GYNECARE LAPAROSCOPIC MORCELLATOR ETHICON, INC.
K003587 11/21/2000 CLEARGLIDE PRECISION BIPOLAR DEVICE ETHICON, INC.
K984220 11/25/1998 MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC.
K170767 03/14/2017 Surgical Stainless Steel Suture, Stainless Steel Suture Ethicon, Inc.
K051701 06/24/2005 VICRYL * MESH BAG ETHICON, INC.
K050845 04/04/2005 MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, INC.
K052953 10/20/2005 NUVANCE* FACIAL REJUVENATION SYSTEM ETHICON, INC.
K052999 10/25/2005 SEMPERFLO INFUSION SYSTEM ETHICON, INC.
K221744 06/16/2022 STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device Ethicon, Inc.
K950272 01/23/1995 PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM ETHICON, INC.
K952687 06/12/1995 PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM ETHICON, INC.
K962480 06/26/1996 COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED ETHICON, INC.
K964072 10/11/1996 MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED ETHICON, INC.
K955646 12/12/1995 VICRYL PERIDONTAL MESH ETHICON, INC.
K970317 01/27/1997 MODIFIED E-PACK PROCEDURE KIT ETHICON, INC.
K960653 02/15/1996 MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) ETHICON, INC.
K962530 06/28/1996 PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC.
K963329 08/23/1996 ETHICON ENDOSUTURE SYSTEM ETHICON, INC.
K964345 10/31/1996 ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED ETHICON, INC.
K173923 12/26/2017 Temporary Cardiac Pacing Wire Ethicon, Inc.
K093845 12/15/2009 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 ETHICON, INC.
K002672 08/28/2000 VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC.
K022269 07/15/2002 COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, INC.
K092590 08/24/2009 PDS PLATES ETHICON, INC.
K212380 08/02/2021 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture Ethicon, Inc.
K181268 05/14/2018 PROLENE (Polypropylene) 3D Patch Ethicon, Inc.
K191373 05/23/2019 VICRYL Mesh Ethicon, Inc.
K100423 02/16/2010 DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 ETHICON, INC.
K213512 11/02/2021 DERMABOND PRINEO Skin Closure System Ethicon, Inc.
K063562 11/27/2006 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC.
K071249 05/04/2007 ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV ETHICON, INC.
K052401 09/01/2005 GYNECARE TVT SECUR SYSTEM ETHICON, INC.
K960476 02/01/1996 ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE ETHICON, INC.
K031847 06/16/2003 CARDIOVATIONS RETRACTOR ETHICON, INC.
K031846 06/16/2003 CARDIOVATIONS OPTICAL BIPOLAR DEVICE ETHICON, INC.
K141776 07/02/2014 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, INC.
K032339 07/29/2003 CARDIOVATIONS PORTABLE VIDEO SYSTEM ETHICON, INC.
K132580 08/16/2013 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC.
K113004 10/07/2011 PDS(TM) BARBED SUTURES ETHICON, INC.
K023880 11/21/2002 CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, INC.
K001625 05/17/2000 PRONOVA NONABSORBABLE SUTURE, USP ETHICON, INC.
K031925 06/23/2003 PROCEED TRILAMINATE SURGICAL MESH ETHICON, INC.
K032420 08/05/2003 MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC.
K022715 08/15/2002 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE ETHICON, INC.
K033337 10/17/2003 ULTRAPRO MESH ETHICON, INC.
K033746 12/01/2003 MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, INC.
K133198 10/17/2013 ULTRAPRO COMFORT PLUG ETHICON, INC.
K131656 06/06/2013 MORCELLEX SIGMA GENERATOR ETHICON, INC.
K113205 10/31/2011 ARTISYN Y-SHAPED MESH ETHICON, INC.
K042603 09/24/2004 GYNECARE PROLENE FASTENER SYSTEM ETHICON, INC.
K033568 11/12/2003 GYNECARE TVT OBTURATOR SYSTEM ETHICON, INC.
K172089 07/11/2017 PROLENE Soft Polypropylene Mesh Ethicon, Inc.
K183183 11/19/2018 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture Ethicon, Inc.
K100485 02/19/2010 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC.
K100936 04/05/2010 GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, INC.
K141560 06/12/2014 ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, INC.
K132054 07/03/2013 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC.
K142822 09/30/2014 PLIASURE Polyglycolide Synthetic Absorbable Suture ETHICON, Inc.
K123114 10/03/2012 ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, INC.
K201143 04/29/2020 VICRYL Mesh Ethicon, Inc.


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