Data / Medical devices / United States / Ethicon, LLC

Ethicon, LLC: FDA-registered device maker in Guaynabo, PR, United States, 29 510(k) clearances and 1 PMA approval

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

Ethicon, LLC is registered with the FDA (registration 3007791599) in Guaynabo, PR, United States. It lists 16 device types. The FDA files 29 510(k) clearances and 1 PMA approval under its listings, the newest dated May 18, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007791599
Address: 475 C Street Los Frailes Industrial Park, Suite 401, Guaynabo, PR, United States, 00969
Owner or operator: ETHICON, LLC (10029715)
Roles: Manufacturer
First device listed: June 18, 2009
Registered through: 2026
Brand names listed: BONE WAX, CAPROFYL, CHROMIC and PLAIN GUT, Coated VICRYL, Coated VICRYL Plus, Coated VICRYL Plus Antibacterial (Polyglactin 910) Absorbable Suture, Cotton Umbilical Tape, ETHIBOND and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic	GAN	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Manufacturer	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	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Manufacturer	accessdata.fda.gov
Wax, Bone	MTJ	U	Manufacturer	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 21, 2020	K201996	Monocryl Plus Antibacterial Suture	GAM	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
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
November 1, 2017	K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	GAQ	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
April 7, 2010	K093845	ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25	GDW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 14, 2006	K061037	PDS PLUS ANTIBACTERIAL SUTURE	NEW	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
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
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

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
January 28, 1982	N18331	PDS SUTURE (DYED)	NEW	27	May 12, 1997	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 15, 2025	97471	Class II	Ongoing	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.	Potential for barb non-engagement.	accessdata.fda.gov
August 10, 2023	92843	Class II	Ongoing	PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP	Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.	accessdata.fda.gov

Compare with other makers

Updated May 18, 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.