Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien, Formerly US Surgical A Divison of Tyco H · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
119 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131705 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-07-01 | 20 | 0 |
| K130532 | IDRIVE ULTRA STERILIZATION TRAY | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-05-30 | 90 | 0 |
| K130717 | ENDO GIA RELOAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-04-18 | 34 | 0 |
| K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-03-14 | 21 | 0 |
| K122781 | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-02-05 | 147 | 0 |
| K123318 | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-12-18 | 54 | 0 |
| K121510 | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-07-25 | 65 | 0 |
| K120061 | WOUND PROTECTOR | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-03-27 | 78 | 0 |
| K120258 | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOG | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-02-29 | 33 | 0 |
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-10-25 | 119 | 49 |
| K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-09-01 | 16 | 6 |
| K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-06-03 | 10 | 2 |
| K103263 | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOG | Covidien, Formerly US Surgical A Divison of Tyco H | 2010-11-22 | 18 | 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