510(k) Report

FDA applicant

Covidien, Formerly Valleylab, A Division of Tyco

Boulder, CO1 decision2011–20110 recalls

FDA records 1 decision for Covidien, Formerly Valleylab, A Division of Tyco (Boulder, CO) in 2011: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). Its devices cite 4 predicates, 0 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

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)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 by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision…Covidien, Formerly Valleylab, A Division of Tyco · 20114cite it

What has FDA decided for it lately?

  • K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision…Covidien, Formerly Valleylab, A Division of Tyco · 2011

The one decision as Covidien, Formerly Valleylab, A Division of Tyco →

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 Valleylab, A Division of Tyco H 6Covidien, 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) 1