Covidien, Formerly US Surgical A Divison of Tyco H
North Haven, CT, US
Covidien, Formerly US Surgical A Divison of Tyco H appears in FDA device records in North Haven, CT. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Covidien, Formerly US Surgical A Divison of Tyco H between 2010 and 2013. The busiest year on record is 2013, with 5. The most recent is 2013, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131705 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | |
| K130532 | IDRIVE ULTRA STERILIZATION TRAY | KCT | Substantially Equivalent | |
| K130717 | ENDO GIA RELOAD | GDW | Substantially Equivalent | |
| K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | |
| K122781 | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | GDW | Substantially Equivalent | |
| K123318 | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | GDW | Substantially Equivalent | |
| K121510 | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | GDW | Substantially Equivalent | |
| K120061 | WOUND PROTECTOR | GCJ | Substantially Equivalent | |
| K120258 | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS | GDW | Substantially Equivalent | |
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | Substantially Equivalent | |
| K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | |
| K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... | GAM | Substantially Equivalent | |
| K103263 | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY | GDW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain