Covidien, Formerly US Surgical A Divison of Tyco H: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Covidien, Formerly US Surgical A Divison of Tyco H” (first 2010, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 60 |
| 2013 | 5 | 34 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 8 | 8 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
Most recent Covidien, Formerly US Surgical A Divison of Tyco H 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131705 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | 2013-07-01 | 20 |
| K130532 | IDRIVE ULTRA STERILIZATION TRAY | KCT | 2013-05-30 | 90 |
| K130717 | ENDO GIA RELOAD | GDW | 2013-04-18 | 34 |
| K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | 2013-03-14 | 21 |
| K122781 | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | GDW | 2013-02-05 | 147 |
| K123318 | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | GDW | 2012-12-18 | 54 |
| K121510 | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | GDW | 2012-07-25 | 65 |
| K120061 | WOUND PROTECTOR | GCJ | 2012-03-27 | 78 |
| K120258 | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS | GDW | 2012-02-29 | 33 |
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | 2011-10-25 | 119 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Covidien, Formerly US Surgical A Divison of Tyco H.
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.
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.
- Covidien (224 510(k)s)
- Covidien Lp, Formerly Registered AS United States (7 510(k)s)
- Covidien, Formerly Valleylab, A Division of Tyco H (6 510(k)s)
- Covidien, Formerly Nellcor Puritan Bennett, Inc. (5 510(k)s)
- Covidien Lp, Formerly Registered AS Tyco Healthcar (4 510(k)s)
- Covidien Lp, Formerly Registered AS Kendall (3 510(k)s)
- Covidien, LLC( Formerly Beacon Endoscopic Corp.) (2 510(k)s)
- Covidien, LLC, Formerly Registered AS Tyco Healthca (2 510(k)s)
- Covidien Lp, Formerly Know AS Valleylab, A Divison (2 510(k)s)
- Covidien (Part of Medtronic) (2 510(k)s)
- Covidien (Dba Medtronic) (1 510(k)s)
- Covidien, Formerly Valleylab, (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Covidien, Formerly US Surgical A Divison of Tyco H?
FDA lists 13 510(k) clearances under the applicant name “Covidien, Formerly US Surgical A Divison of Tyco H” (first 2010, latest 2013), across 4 product codes in 2 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 Covidien, Formerly US Surgical A Divison of Tyco H?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covidien, Formerly US Surgical A Divison of Tyco H is 34 days.
Which FDA product codes appear under Covidien, Formerly US Surgical A Divison of Tyco H?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 8); GCJ (Laparoscope, General & Plastic Surgery, 3); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1).
Next steps
- See all 13 Covidien, Formerly US Surgical A Divison of Tyco H clearances with predicates and recalls
- Run predicate analysis for product code GDW, Covidien, Formerly US Surgical A Divison of Tyco H'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.