Ethicon Endo-Surgery, LLC: FDA filings under this applicant name
FDA lists 71 510(k) clearances under 2 spellings of the applicant name “Ethicon Endo-Surgery, LLC” (first 2006, latest 2026), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 111 days, against 111 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 | 5 | 45 |
| 2013 | 9 | 126 |
| 2014 | 2 | 93 |
| 2015 | 3 | 131 |
| 2016 | 4 | 146 |
| 2017 | 4 | 72 |
| 2018 | 4 | 110 |
| 2019 | 2 | 122 |
| 2020 | 5 | 75 |
| 2021 | 3 | 214 |
| 2022 | 2 | 136 |
| 2023 | 3 | 58 |
| 2024 | 2 | 86 |
| 2025 | 3 | 111 |
| 2026 | 3 | 119 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ethicon Endo-Surgery, LLC took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 27 | 27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 15 | 15 |
| LFL | Instrument, Ultrasonic Surgical | 14 | 14 |
| FZP | Clip, Implantable | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 3 | 3 |
| GAG | Stapler, Surgical | 2 | 2 |
| KNW | Instrument, Biopsy | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ethicon Endo-Surgery, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | GEI | 2026-09-17 | 268 |
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | GDW | 2026-05-11 | 109 |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | OXC | 2026-01-09 | 119 |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | GDW | 2025-12-17 | 111 |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | GDW | 2025-05-14 | 55 |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | GDW | 2025-02-25 | 132 |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | GDW | 2024-10-28 | 144 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | GAG | 2024-07-03 | 27 |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | FZP | 2023-08-29 | 27 |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | GEI | 2023-04-13 | 58 |
61 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 1 recall events; 4 initiated in the last five years. Most recent: 2025-03-07.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ethicon Endo-Surgery, LLC (70)
- Ethicon Endo Surgery, LLC (1)
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. (205 510(k)s)
- Ethicon Endo-Surgery, Inc. (114 510(k)s)
- Ethicon Endo-Sugery, LLC (6 510(k)s)
- Ethicon, 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 GmbH (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-Surgery, LLC?
FDA lists 71 510(k) clearances under 2 spellings of the applicant name “Ethicon Endo-Surgery, LLC” (first 2006, latest 2026), across 11 product codes in 3 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 Endo-Surgery, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ethicon Endo-Surgery, LLC is 98 days. Since 2017: 111 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ethicon Endo-Surgery, LLC?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 27); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 15); LFL (Instrument, Ultrasonic Surgical, 14).
Next steps
- See all 71 Ethicon Endo-Surgery, LLC clearances with predicates and recalls
- Run predicate analysis for product code GDW, Ethicon Endo-Surgery, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.