510(k) Report

FDA applicant

Liger Medical, LLC

Draper, UT3 decisions2014–20210 recalls

FDA records 3 decisions for Liger Medical, LLC (Draper, UT) from 2014 to 2021: 3 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 4 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Liger Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12016: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Liger Medical, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HGIElectrocautery, Gynecologic (And Accessories)2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152843Liger Medical HTU-110Liger Medical, LLC · 20161cites it

What has FDA decided for it lately?

  • K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021
  • K152843Liger Medical HTU-110Liger Medical, LLC · 2016
  • K133273Liger Medical Esu-110Liger Medical, LLC · 2014

All 3 as Liger Medical, LLC →