Covidien, Formerly Valleylab, A Division of Tyco H: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Covidien, Formerly Valleylab, A Division of Tyco H” (first 2011, latest 2014), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 104 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 | 1 | 278 |
| 2013 | 3 | 83 |
| 2014 | 1 | 72 |
| 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Review panels
Most recent Covidien, Formerly Valleylab, A Division of Tyco H 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | LFL | 2014-08-07 | 72 |
| K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) | GEI | 2013-12-20 | 51 |
| K131170 | SONICISION STERILIZATION TRAY | KCT | 2013-08-28 | 126 |
| K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER | GEI | 2013-01-30 | 83 |
| K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | GEI | 2012-09-05 | 278 |
| K102913 | FORCETRIAD | GEI | 2011-05-06 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Covidien, Formerly Valleylab, A Division 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, Formerly US Surgical A Divison of Tyco H (13 510(k)s)
- Covidien Lp, Formerly Registered AS United States (7 510(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 Valleylab, A Division of Tyco H?
FDA lists 6 510(k) clearances under the applicant name “Covidien, Formerly Valleylab, A Division of Tyco H” (first 2011, latest 2014), across 3 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 Valleylab, A Division of Tyco H?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covidien, Formerly Valleylab, A Division of Tyco H is 104 days.
Which FDA product codes appear under Covidien, Formerly Valleylab, A Division of Tyco H?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1); LFL (Instrument, Ultrasonic Surgical, 1).
Next steps
- See all 6 Covidien, Formerly Valleylab, A Division of Tyco H clearances with predicates and recalls
- Run predicate analysis for product code GEI, Covidien, Formerly Valleylab, A Division 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.