Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien Lp, Formerly Registered AS United States · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
135 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091869 | SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SI | Covidien Lp, Formerly Registered AS United States | 2009-09-01 | 70 | 0 |
| K091900 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-07-16 | 21 | 0 |
| K083519 | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADIN | Covidien Lp, Formerly Registered AS United States | 2009-04-10 | 135 | 0 |
| K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-03-09 | 19 | 0 |
| K082619 | SILS PORT, MODELS SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008-11-07 | 59 | 0 |
| K082659 | MODIFIED ENDO STICH | Covidien Lp, Formerly Registered AS United States | 2008-09-19 | 7 | 0 |
| K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | Covidien Lp, Formerly Registered AS United States | 2008-05-23 | 29 | 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