510(k) Report

FDA applicant

Valleylab, Inc.

Boulder, CO104 decisions1976–200934 recalls

FDA records 104 decisions for Valleylab, Inc. (Boulder, CO) from 1976 to 2009: 104 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 43 predicates, 27 of them its own earlier devices. 34 recalls are linked to its devices.

FDA’s records also spell it “Valleylab”.

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 Valleylab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2010: 12011: 32013: 12014: 12016: 252017: 1
2007high 25 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Valleylab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories69decisions
  • LFLInstrument, Ultrasonic Surgical9decisions
  • FRNPump, Infusion7decisions
  • FPASet, Administration, Intravascular4decisions
  • HGIElectrocautery, Gynecologic (And Accessories)3decisions
  • GEHUnit, Cryosurgical, Accessories2decisions

Also: LBK (2), KGF (1), BWA (1), GXY (1), HGZ (1), FYD (1).

Whose devices does it build on?

Its devices cite 43 predicates; 27 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 201 times; 27 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.

  • K944602Valleylab Force FXValleylab, Inc. · 199522cite it
  • K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 199816cite it
  • K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 199811cite it
  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20039cite it
  • K962044Valleylab Coated ElectrodesValleylab, Inc. · 19968cite it
  • K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 20057cite it

What has FDA decided for it lately?

  • K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 20091 recall
  • K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044Valleylab · 2006
  • K053535Vivawave Microwave Ablation SystemValleylab · 2006
  • K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
  • K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
  • K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
  • K051627Valleylab G3000 Electrosurgical InstrumentValleylab · 2005
  • K043273Ligasure Vessel Sealing System. Ligasure InstrumentsValleylab · 2005

All 94 as Valleylab, Inc. →All 10 as Valleylab →

What has been recalled?

34 recalls linked to its devices; the latest:

  • K964175Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk…Jan 26, 2017Class II
  • K926481Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The…Jul 8, 2016Class II
  • K926481Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The…Jul 8, 2016Class II
  • K926481Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab…Jul 8, 2016Class II
  • K926481Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The…Jul 8, 2016Class II
  • K926481Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab…Jul 8, 2016Class II

Other applicant names beginning “Valleylab”

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

Valleylab,A Division of Tyco Healthcare Group LP 2