Liger Medical HTU-110

FDA 510(k) K152843 · Liger Medical, LLC

Substantially Equivalent

510(k) numberK152843

Submission

Device name
Liger Medical HTU-110
Applicant
Liger Medical, LLC
Draper, UT, US
Received
September 29, 2015
Decision date
June 24, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HGI – Electrocautery, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4120
Specialty
Obstetrics/Gynecology

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More from R-Group Intl.

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Questions and answers

When was Liger Medical HTU-110 cleared by the FDA?

Liger Medical HTU-110 (K152843) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 269 days after the submission was received.

What is the product code of K152843?

The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.