Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

ETHICON, Inc. — Predicate Candidate Screening

205 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time

230 days90th percentile

205clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253394	Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture	ETHICON, Inc.	2026-06-25	268	0
K252047	STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devic	ETHICON, Inc.	2026-05-18	322	0
K253572	STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Co	ETHICON, Inc.	2026-03-27	130	0
K253852	MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilame	ETHICON, Inc.	2026-02-06	66	0
K252743	STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device;	ETHICON, Inc.	2025-12-22	116	0
K243897	PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Ab	ETHICON, Inc.	2025-11-12	328	0
K221744	STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Dev	ETHICON, Inc.	2022-11-15	152	0
K212380	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Abs	ETHICON, Inc.	2022-02-22	204	1
K213512	DERMABOND PRINEO Skin Closure System	ETHICON, Inc.	2021-12-07	35	0
K201996	Monocryl Plus Antibacterial Suture	ETHICON, Inc.	2020-12-21	154	1
K201686	GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides Sy	ETHICON, Inc.	2020-09-17	87	0
K201143	VICRYL Mesh	ETHICON, Inc.	2020-08-06	99	0
K192144	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Cont	ETHICON, Inc.	2020-03-25	230	1
K192580	STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissu	ETHICON, Inc.	2019-12-18	90	1
K191373	VICRYL Mesh	ETHICON, Inc.	2019-10-22	152	0
K183183	VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical	ETHICON, Inc.	2019-06-27	220	3
K182873	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices	ETHICON, Inc.	2019-01-10	90	5
K181652	Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable	ETHICON, Inc.	2018-09-28	98	1
K181151	GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturat	ETHICON, Inc.	2018-08-10	101	0
K173923	Temporary Cardiac Pacing Wire	ETHICON, Inc.	2018-08-02	219	0
K181268	PROLENE (Polypropylene) 3D Patch	ETHICON, Inc.	2018-07-26	73	0
K173019	GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigi	ETHICON, Inc.	2018-07-06	281	0
K180910	ULTRAPRO Mesh and ULTRAPRO ADVANCED	ETHICON, Inc.	2018-07-02	87	0
K173162	GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reu	ETHICON, Inc.	2018-06-28	272	0
K180829	PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical	ETHICON, Inc.	2018-06-28	90	0
K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	ETHICON, Inc.	2017-11-01	232	0
K172089	PROLENE Soft Polypropylene Mesh	ETHICON, Inc.	2017-10-05	86	0
K163152	PROLENE Soft Polypropylene Mesh	ETHICON, Inc.	2017-03-11	121	0
K161726	E-Pack Procedure Kit	ETHICON, Inc.	2016-07-12	20	0
K152490	DERMABOND PRINEO Skin Closure System	ETHICON, Inc.	2015-11-25	85	0
K152096	DERMABOND Advanced Topical Skin Adhesive, High Viscosity DER	ETHICON, Inc.	2015-10-22	86	0
K151200	STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, ST	ETHICON, Inc.	2015-08-13	100	1
K150670	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device	ETHICON, Inc.	2015-07-02	108	0
K142822	PLIASURE Polyglycolide Synthetic Absorbable Suture	ETHICON, Inc.	2015-03-26	177	0
K141560	ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE	ETHICON, Inc.	2014-10-23	133	0
K141776	STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES	ETHICON, Inc.	2014-10-15	105	0
K133198	ULTRAPRO COMFORT PLUG	ETHICON, Inc.	2014-05-30	225	0
K133864	DERMABOND PRINEO SKIN CLOSURE SYSTEM	ETHICON, Inc.	2014-03-10	81	0
K132580	COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC	ETHICON, Inc.	2014-02-28	196	0
K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	ETHICON, Inc.	2013-12-06	36	2
K131656	MORCELLEX SIGMA GENERATOR	ETHICON, Inc.	2013-09-27	113	0
K132054	GYNECARE TVT EXACT CONTINENCE SYSTEM	ETHICON, Inc.	2013-08-23	51	0
K123114	ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE	ETHICON, Inc.	2013-02-05	125	0
K113205	ARTISYN Y-SHAPED MESH	ETHICON, Inc.	2012-06-11	224	0
K113004	PDS(TM) BARBED SUTURES	ETHICON, Inc.	2011-12-20	74	1
K111751	VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT I	ETHICON, Inc.	2011-12-02	163	0
K100936	GYNECARE TVT ABBREVO CONTINENCE SYSTEM	ETHICON, Inc.	2010-07-01	87	0
K100423	DERMABOND NX ADHESIVE MODEL: DNX6, DNX12	ETHICON, Inc.	2010-05-04	77	0
K093845	ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MO	ETHICON, Inc.	2010-04-07	113	1
K100280	GYNCARE MORCELLEX TISSUE MORCELLATOR	ETHICON, Inc.	2010-03-24	51	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda