Ethicon Endo-Surgery, Inc.: FDA filings under this applicant name
FDA lists 114 510(k) clearances under 3 spellings of the applicant name “Ethicon Endo-Surgery, Inc.” (first 1992, latest 2023), plus 1 De Novo decision, across 25 product codes in 5 review panels. Median 510(k) review time under this name: 84 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 | 1 | 129 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 114 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ethicon Endo-Surgery, Inc. took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 28 | 28 |
| GDW | Staple, Implantable | 17 | 17 |
| LFL | Instrument, Ultrasonic Surgical | 15 | 15 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 | 11 |
| OCW | Endoscopic Tissue Approximation Device | 10 | 10 |
| KNW | Instrument, Biopsy | 6 | 6 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| GAG | Stapler, Surgical | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
Plus 15 more product codes.
Review panels
- General and Plastic Surgery (90)
- Gastroenterology and Urology (18)
- General Hospital (3)
- 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 |
|---|---|---|---|---|
| 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 |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | GEI | 2020-05-27 | 114 |
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | GDW | 2014-11-24 | 129 |
| K111195 | VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS | GDW | 2011-08-03 | 97 |
| K110385 | ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER | GDW | 2011-03-25 | 43 |
| K101520 | ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH | GEI | 2010-12-10 | 191 |
| K102632 | ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER | GDW | 2010-10-07 | 24 |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | FER | 2010-03-25 | 97 |
| K091259 | ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS | GEI | 2010-01-15 | 261 |
| K091824 | ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 | GEI | 2009-11-27 | 161 |
104 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 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 Endo-Surgery, Inc. is the 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 the product codes filed under Ethicon Endo-Surgery, Inc. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ethicon Endo-Surgery, Inc. (111)
- Ethicon Endo-Surgery (3)
- Ethicon Endo Surgery, Inc. (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, LLC (71 510(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, Inc.?
FDA lists 114 510(k) clearances under 3 spellings of the applicant name “Ethicon Endo-Surgery, Inc.” (first 1992, latest 2023), plus 1 De Novo decision, across 25 product codes in 5 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ethicon Endo-Surgery, Inc. is 84 days.
Which FDA product codes appear under Ethicon Endo-Surgery, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 28); GDW (Staple, Implantable, 17); LFL (Instrument, Ultrasonic Surgical, 15).
Next steps
- See all 114 Ethicon Endo-Surgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Ethicon Endo-Surgery, 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 (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.