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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