Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ethicon Endo-Surgery · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223760 | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cu | Ethicon Endo-Surgery | 2023-03-15 | 90 | 1 |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, | Ethicon Endo-Surgery | 2020-05-27 | 114 | 0 |
| DEN110016 | PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS | Ethicon Endo-Surgery | 2012-04-30 | 222 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda