Ethicon Endo-Sugery, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ethicon Endo-Sugery, LLC” (first 2008, latest 2011), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FZP | Clip, Implantable | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| NEU | Marker, Radiographic, Implantable | 1 | 1 |
Review panels
Most recent Ethicon Endo-Sugery, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112033 | ENSEAL G2 TISSUS SEALERS | GEI | 2011-11-08 | 116 |
| K101990 | ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 | GEI | 2011-06-13 | 333 |
| K110699 | LIGAMAX 5 | FZP | 2011-03-25 | 11 |
| K091211 | EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS | GCJ | 2009-09-04 | 130 |
| K082278 | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS | NEU | 2008-12-16 | 127 |
| K080972 | ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP | GDW | 2008-07-03 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Ethicon Endo-Sugery, LLC.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ethicon Endo-Sugery, LLC (a text match, not an official crosswalk):
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, Inc. (208 510(k)s)
- Ethicon Endo-Surgery, Inc. (183 510(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 Endo-Sugery, LLC?
FDA lists 6 510(k) clearances under the applicant name “Ethicon Endo-Sugery, LLC” (first 2008, latest 2011), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ethicon Endo-Sugery, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ethicon Endo-Sugery, LLC is 122 days.
Which FDA product codes appear under Ethicon Endo-Sugery, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); FZP (Clip, Implantable, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 6 Ethicon Endo-Sugery, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ethicon Endo-Sugery, LLC'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.