Data / Medical devices / United States / Ethicon, Inc.

Ethicon, Inc.: FDA-registered device maker in Raritan, NJ, United States, 54 510(k) clearances and 4 PMA approvals

Name: Ethicon, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ethicon, Inc. is registered with the FDA (registration 3017102971) in Raritan, NJ, United States. It lists 32 device types. The FDA files 54 510(k) clearances and 4 PMA approvals under its listings, the newest dated May 18, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Ethicon, Inc.

FDA registration number: 3017102971
Address: 1000 Route 202, Raritan, NJ, United States, 08869
Owner or operator: ETHICON INC. (2210968)
Roles: Manufacturer, Specification developer
First device listed: December 20, 1991
Registered through: 2026
Brand names listed: Artisyn Y-Shaped Mesh, BLAKE Cardio Connector, BLAKE Silicone Drain, BONE WAX, COATED VICRYL SUTURE, Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture, Cotton Umbilical Tape and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	SGV	3	Manufacturer	accessdata.fda.gov
Agent, Absorbable Hemostatic, Non-Collagen Based	LMG	3	Specification developer	accessdata.fda.gov
Barrier, Absorbable, Adhesion	MCN	3	Specification developer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Clip, Implantable	FZP	2	Manufacturer	accessdata.fda.gov
Cutaneous Tissue Adhesive With Mesh	OMD	2	Specification developer	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Specification developer	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Specification developer	accessdata.fda.gov
Fibrin Sealant Preparation Device	MZM	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	OTO	2	Specification developer	accessdata.fda.gov
Needle, Cerclage, Gynecological	HDH	1	Specification developer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Manufacturer, Specification developer	accessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, Absorbable	NHB	2	Manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Specification developer	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic	GAN	2	Specification developer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer, Specification developer	accessdata.fda.gov
Suture, Nonabsorbable	GAO	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer, Specification developer	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Manufacturer, Specification developer	accessdata.fda.gov
Tissue Adhesive For The Topical Approximation Of Skin	MPN	2	Specification developer	accessdata.fda.gov
Wax, Bone	MTJ	U	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 18, 2026	K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 27, 2026	K253572	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 6, 2026	K253852	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 22, 2025	K252743	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
November 12, 2025	K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
November 15, 2022	K221744	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 22, 2022	K212380	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 7, 2021	K213512	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 21, 2020	K201996	Monocryl Plus Antibacterial Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 6, 2020	K201143	VICRYL Mesh	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 25, 2020	K192144	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 18, 2019	K192580	STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 22, 2019	K191373	VICRYL Mesh	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 27, 2019	K183183	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	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 10, 2019	K182873	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	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
September 28, 2018	K181652	Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 2, 2018	K173923	Temporary Cardiac Pacing Wire	LDF	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 26, 2018	K181268	PROLENE (Polypropylene) 3D Patch	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 2, 2018	K180910	ULTRAPRO Mesh and ULTRAPRO ADVANCED	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 28, 2018	K180829	PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
November 1, 2017	K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	GAQ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 5, 2017	K172089	PROLENE Soft Polypropylene Mesh	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
April 21, 2017	K163645	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	Ethicon, LLC	accessdata.fda.gov
November 25, 2015	K152490	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 22, 2015	K152096	DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive	MPN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 23, 2014	K141560	ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
May 30, 2014	K133198	ULTRAPRO COMFORT PLUG	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 28, 2014	K132580	COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 6, 2013	K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 5, 2013	K123114	ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE	GDW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 11, 2012	K113205	ARTISYN Y-SHAPED MESH	OTO	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
April 7, 2010	K093845	ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25	GDW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 17, 2010	K092590	PDS PLATES	NHB	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 5, 2007	K071249	ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 14, 2006	K061037	PDS PLUS ANTIBACTERIAL SUTURE	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
May 25, 2006	K060713	PROCEED SURGICAL MESH	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 9, 2005	K051732	ENDOSCOPIC APPLICATOR	GCJ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 29, 2005	K050845	MONOCRYL PLUS ANTIBACTERIAL SUTURE	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 18, 2003	K033746	MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 22, 2003	K032420	MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
September 13, 2002	K022269	COATED VICRYL* (POLYGLACTIN 910) SUTURE	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 8, 2002	K013718	GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR	OTO	Substantially Equivalent	Gynecare, A Div. of Ethicon, Inc.	accessdata.fda.gov
November 7, 2000	K003070	ETHIBOND EXCEL VALVE LOOP SUTURE	DXZ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 10, 2000	K001625	PRONOVA NONABSORBABLE SUTURE, USP	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 23, 1999	K984220	MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 18, 1996	K964072	MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED	GAN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 25, 1996	K963329	ETHICON ENDOSUTURE SYSTEM	GCJ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 28, 1996	K960653	MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)	GAN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 9, 1995	K946173	STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK	GAQ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 7, 1994	K931271	ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE	GAQ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 24, 1993	K931492	LAPRA-TY* SUTURE CLIP	FZP	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 31, 1984	K843187	CANNULA	GEA	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 12, 1981	K811872	TEFLON PLEDGET SUTURE BUTTRESS	DXZ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 13, 1981	K810428	VICRYL	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 15, 2025	P240035	ETHIZIA	SGV	6	August 27, 2026	accessdata.fda.gov
September 15, 1989	P880047	INTERCEED TC7 ABSORBABLE ADHESION BARRIER	MCN	65	June 25, 2026	accessdata.fda.gov
January 28, 1982	N18331	PDS SUTURE (DYED)	NEW	27	May 12, 1997	accessdata.fda.gov
October 14, 1960	N12159	SURGICEL BRAND ABSORBABLE HEMOSTAT	LMG	120	July 28, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 25, 2024	95516	Class II	Ongoing	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H	Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.	accessdata.fda.gov
May 10, 2024	94643	Class II	Ongoing	VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J21	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection.	accessdata.fda.gov
March 8, 2024	94220	Class II	Ongoing	STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of ab	Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility	accessdata.fda.gov
March 31, 2023	92084	Class II	Ongoing	PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: P	Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved	accessdata.fda.gov

Compare with other makers

Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.