Ethicon Endo-Surgery, Inc.: FDA clearances and approvals
Ethicon Endo-Surgery, Inc. has 183 FDA 510(k) clearances (first 1992, latest 2026), plus 1 De Novo decision, across 28 product codes in 5 review panels. Median 510(k) review time: 86 days. Since 2017 its median was 112 days, against 108 days for all cleared 510(k)s in the same product codes. openFDA lists 174 product recalls by a recalling firm named Ethicon Endo-Surgery, Inc. It is the industry lead sponsor of 31 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 45 |
| 2013 | 9 | 126 |
| 2014 | 3 | 129 |
| 2015 | 3 | 131 |
| 2016 | 4 | 146 |
| 2017 | 4 | 72 |
| 2018 | 4 | 110 |
| 2019 | 2 | 122 |
| 2020 | 6 | 94 |
| 2021 | 3 | 214 |
| 2022 | 2 | 136 |
| 2023 | 3 | 90 |
| 2024 | 2 | 86 |
| 2025 | 3 | 111 |
| 2026 | 3 | 119 |
Review time against the same product codes
Since 2017, Ethicon Endo-Surgery, Inc.'s cleared 510(k)s took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 44 | 44 |
| GCJ | Laparoscope, General & Plastic Surgery | 31 | 31 |
| LFL | Instrument, Ultrasonic Surgical | 29 | 29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 26 | 26 |
| OCW | Endoscopic Tissue Approximation Device | 11 | 11 |
| KNW | Instrument, Biopsy | 7 | 7 |
| GAG | Stapler, Surgical | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
Plus 18 more product codes.
Review panels
- General and Plastic Surgery (157)
- Gastroenterology and Urology (19)
- General Hospital (4)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (1)
Most recent Ethicon Endo-Surgery, Inc. 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 |
| 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 |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) | GDW | 2023-03-15 | 90 |
173 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110016 | De Novo | Percutaneous Surgical Set With Attachments | 2012-04-30 |
Recalls
174 product recalls in 47 recall events; 3 initiated in the last five years. Most recent: 2025-09-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Ethicon Endo-Surgery, Inc. is the industry lead sponsor of 31 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06608485: A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures (Recruiting, started 2025-01-23)
- NCT05519215: A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures (Completed, started 2023-03-22)
- NCT05067647: A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures (Completed, started 2021-11-29)
- NCT05039021: A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices (Completed, started 2021-07-29)
- NCT04763421: A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures (Completed, started 2021-04-22)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ethicon Endo-Surgery, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Ethicon Endo-Surgery, Inc. have?
Ethicon Endo-Surgery, Inc. has 183 FDA 510(k) clearances (first 1992, latest 2026), plus 1 De Novo decision, across 28 product codes in 5 review panels.
How long does FDA take to clear Ethicon Endo-Surgery, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ethicon Endo-Surgery, Inc.'s cleared 510(k)s is 86 days. Since 2017: 112 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Ethicon Endo-Surgery, Inc. make?
Its most frequent FDA product codes are GDW (Staple, Implantable, 44); GCJ (Laparoscope, General & Plastic Surgery, 31); LFL (Instrument, Ultrasonic Surgical, 29).
Has Ethicon Endo-Surgery, Inc. had device recalls?
openFDA lists 174 product recalls in 47 recall events by a recalling firm whose name matches Ethicon Endo-Surgery, Inc; the most recent began 2025-09-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 183 Ethicon Endo-Surgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Ethicon Endo-Surgery, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.