510(k) Report

FDA applicant

Covidien, Formerly Valleylab, A Division of Tyco H

Boulder, CO6 decisions2011–20140 recalls

FDA records 6 decisions for Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, CO) from 2011 to 2014: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KCT (Sterilization Wrap Containers, Trays…). Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Covidien, Formerly Valleylab, A Division of Tyco H’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 12013: 32014: 1
2011high 3 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Covidien, Formerly Valleylab, A Division of Tyco H by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Covidien, Formerly Valleylab, A…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision
  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 20129cite it
  • K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 20137cite it
  • K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 20136cite it
  • K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H · 20142cite it
  • K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 20131cites it
  • K102913ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H · 20111cites it

What has FDA decided for it lately?

  • K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H · 2014
  • K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
  • K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 2013
  • K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013
  • K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
  • K102913ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H · 2011

All 6 as Covidien, Formerly Valleylab, A Division of Tyco H →

Other applicant names beginning “Covidien”

FDA records each applicant name separately; these may or may not be the same firm.

Covidien 227Covidien, Formerly US Surgical A Divison of Tyco H 13Covidien Lp, Formerly Registered AS United States 8Covidien, Formerly Nellcor Puritan Bennett, Inc. 5Covidien Lp, Formerly Registered AS Tyco Healthcar 4Covidien Lp, Formerly Registered AS Kendall 3Covidien, LLC ( Formerly Beacon Endoscopic Corp.) 2Covidien (Part of Medtronic) 2Covidien, LLC, Formerly Registered AS Tyco Healthca 2Covidien Lp, Formerly Know AS Valleylab, A Divison 2Covidien (Dba Medtronic) 1Covidien UK Manufacturing, Ltd. 1