ETHICON, Inc.: FDA filings under this applicant name
FDA lists 208 510(k) clearances under the applicant name “ETHICON, Inc.” (first 1976, latest 2026), plus 5 PMA decisions, across 58 product codes in 9 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 121 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 224 |
| 2013 | 4 | 82 |
| 2014 | 5 | 133 |
| 2015 | 5 | 100 |
| 2016 | 2 | 94 |
| 2017 | 4 | 120 |
| 2018 | 8 | 100 |
| 2019 | 4 | 121 |
| 2020 | 4 | 126 |
| 2021 | 1 | 35 |
| 2022 | 2 | 178 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 222 |
| 2026 | 4 | 199 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ETHICON, Inc. took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 27 | 27 |
| FTL | Mesh, Surgical, Polymeric | 25 | 25 |
| GCJ | Laparoscope, General & Plastic Surgery | 18 | 18 |
| FZP | Clip, Implantable | 11 | 11 |
| HET | Laparoscope, Gynecologic (And Accessories) | 11 | 11 |
| GDW | Staple, Implantable | 10 | 10 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| GAG | Stapler, Surgical | 6 | 6 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 6 | 6 |
Plus 48 more product codes.
Review panels
- General and Plastic Surgery (157)
- Obstetrics and Gynecology (18)
- Gastroenterology and Urology (12)
- Cardiovascular (10)
- Orthopedic (6)
- General Hospital (2)
- Ophthalmic (2)
- Dental (1)
- Ear, Nose and Throat (1)
Most recent ETHICON, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | GAM | 2026-06-25 | 268 |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | NEW | 2026-05-18 | 322 |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | GAW | 2026-03-27 | 130 |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 | 66 |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | 2025-12-22 | 116 |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 | 328 |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | 2022-11-15 | 152 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 | 204 |
| K213512 | DERMABOND PRINEO Skin Closure System | OMD | 2021-12-07 | 35 |
| K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 | 154 |
198 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240035 | PMA | ETHIZIA | 2025-12-15 |
| P060029 | PMA | ETHICON OMNEX SURGICAL SEALANT | 2010-06-03 |
| P880047 | PMA | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | 1989-09-15 |
| P830079 | PMA | INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT | 1985-10-10 |
| N12159 | PMA | SURGICEL BRAND ABSORBABLE HEMOSTAT | 1960-10-14 |
Recalls
104 product recalls in 55 recall events; 21 initiated in the last five years. Most recent: 2025-08-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named ETHICON, Inc. is the lead sponsor of 36 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06664788: A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery (Recruiting, started 2025-04-16)
- NCT04829175: Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry (Recruiting, started 2022-04-11)
- NCT04829058: GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study (Recruiting, started 2021-11-24)
- NCT04829357: Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System (Recruiting, started 2021-09-09)
- NCT04829994: Post-Market Clinical Follow-Up onTVT EXACT® Continence System (Active not recruiting, started 2021-07-07)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under ETHICON, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ethicon Endo-Surgery, Inc. (183 510(k)s)
- Ethicon Endo-Sugery, LLC (6 510(k)s)
- Ethicon Endo Surgery, LLC (2 510(k)s)
- Ethicon Endo-Suregery, LLC (1 510(k)s)
- Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) (1 510(k)s)
- Ethicon Inc (On Behalf of Omrix Biopharaceuticals (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under ETHICON, Inc.?
FDA lists 208 510(k) clearances under the applicant name “ETHICON, Inc.” (first 1976, latest 2026), plus 5 PMA decisions, across 58 product codes in 9 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by ETHICON, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ETHICON, Inc. is 86 days. Since 2017: 121 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ETHICON, Inc.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 27); FTL (Mesh, Surgical, Polymeric, 25); GCJ (Laparoscope, General & Plastic Surgery, 18).
Next steps
- See all 208 ETHICON, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAM, ETHICON, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.