# ETHICON, Inc.

- Location (FDA's records): Somerville, NJ
- FDA decisions: 213 (1960–2026): 208 510(k) clearances and 5 original PMA approvals
- Names in FDA's records: ETHICON, Inc. (210); Ethicon, LLC (2); Ethicon GmbH (1)
- Product codes: GAM (27), FTL (25), GCJ (18), FZP (11), HET (11), GDW (10), NEW (9), GEI (8), GAG (6), OTN (6), LDF (4), OMD (4)
- 510(k) review time since 2016: median 116 days, against 132 for FDA's reviews in the same codes and years (10 of 23 faster)
- Predicates its devices cite: 109 (72 its own); citations of its devices by later devices: 375 (72 its own)
- Recalls linked to its devices: 122 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Angiotech: 4 (https://510kreport.com/company/angiotech)
- Closure Medical Corp.: 4 (https://510kreport.com/company/closure-medical)
- Surgical Specialties Corp: 3 (https://510kreport.com/company/surgical-specialties)
- Surgical Specialties Corp. Dba Angiotech: 3 (https://510kreport.com/company/surgical-specialties-dba-angiotech)
- Gynecare Center: 2 (https://510kreport.com/company/gynecare-center)
- Gynecare, A Div. of Ethicon, Inc.: 2 (https://510kreport.com/company/gynecare-a-div-of-ethicon)
- Covidien Lp, Formerly Registered AS United States: 2 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)

## Firms that cite its devices most
- Ethicon Endo-Surgery, Inc.: 20 (https://510kreport.com/company/ethicon-endo-surgery)
- Aesculap, Inc.: 11 (https://510kreport.com/company/aesculap)
- Sofradim Production: 7 (https://510kreport.com/company/sofradim-production)
- Internacional Farmaceutica, S.A. DE C.V.: 7 (https://510kreport.com/company/internacional-farmaceutica)
- Demetech Corp.: 6 (https://510kreport.com/company/demetech)
- Surgical Specialties Corp: 5 (https://510kreport.com/company/surgical-specialties)
- M/s. Meril Endo Surgery Private Limited.: 5 (https://510kreport.com/company/m-s-meril-endo-surgery-private)
- W. L. Gore & Associates, Inc.: 5 (https://510kreport.com/company/w-l-gore-associates)

## Its most-cited devices
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk (1995), cited by 19
- K931271: Ethi-Pack* Surgical Stainless Steel Suture (1994), cited by 19
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (2000), cited by 13
- K974098: Pubouurethral Sling (1998), cited by 12
- K944110: Vicryl Rapide Suture (1995), cited by 11
- K022269: Coated Vicryl* (Polyglactin 910) Suture (2002), cited by 11

## Recent decisions
- K253394: Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (Jun 25, 2026)
- K252047: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (May 18, 2026)
- K253572: STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device  STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (Mar 27, 2026)
- K253852: MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (Feb 6, 2026)
- K252743: STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (Dec 22, 2025)
- P240035: Ethizia (Dec 15, 2025)
- K243897: PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (Nov 12, 2025)
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (Nov 15, 2022)

Source page: https://510kreport.com/company/ethicon