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

Ethicon, LLC.: FDA-registered device maker in San Lorenzo, PR, United States, 18 510(k) clearances and 2 PMA approvals

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 2648650) in San Lorenzo, PR, United States. It lists 18 device types. The FDA files 18 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 22, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ethicon, LLC.

FDA registration number: 2648650
Address: Highway 183 Km. 8.3, San Lorenzo, PR, United States, 00754
Owner or operator: ETHICON INC. (2210968)
Roles: Manufacturer, Manufacturer for export
First device listed: December 20, 1991
Registered through: 2026
Brand names listed: DERMABOND ADVANCED Topical Skin Adhesive, DERMABOND Mini Topical Skin Adhesive, DERMABOND PRINEO Skin Closure System (42mm), DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm), DERMABOND ProPen, DERMABOND PRINEO Skin Closure System (22cm), ETHIBOND, ETHIBOND EXCEL and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Absorbable Hemostatic, Non-Collagen Based	LMG	3	Manufacturer	accessdata.fda.gov
Barrier, Absorbable, Adhesion	MCN	3	Manufacturer	accessdata.fda.gov
Cutaneous Tissue Adhesive With Mesh	OMD	2	Manufacturer	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	OTO	2	Manufacturer	accessdata.fda.gov
Needle, Cerclage, Gynecological	HDH	1	Manufacturer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	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, Manufacturer for export	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
Tissue Adhesive For The Topical Approximation Of Skin	MPN	2	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
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 15, 2022	K221744	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 7, 2021	K213512	DERMABOND PRINEO Skin Closure System	OMD	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
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
August 2, 2018	K173923	Temporary Cardiac Pacing Wire	LDF	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
December 6, 2013	K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	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
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

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
September 15, 1989	P880047	INTERCEED TC7 ABSORBABLE ADHESION BARRIER	MCN	65	June 25, 2026	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 23, 2026	99947	Not yet classified	Open, Classified	ETHILON Nylon Suture, Product Code 697G	Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.	accessdata.fda.gov
September 8, 2026	99754	Class II	Ongoing	PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H	Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure,	accessdata.fda.gov
December 20, 2024	96127	Class II	Ongoing	PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgi	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.	accessdata.fda.gov

Compare with other makers

Updated October 23, 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.