IRIS Thermocoagulator and Digital Colposcope

FDA 510(k) K202915 · Liger Medical, LLC

Substantially Equivalent

510(k) numberK202915

Submission

Device name
IRIS Thermocoagulator and Digital Colposcope
Applicant
Liger Medical, LLC
Lehi, UT, US
Received
September 29, 2020
Decision date
April 23, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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K152843Liger Medical HTU-110HGI · Traditional 06/24/2016SE
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Questions and answers

When was IRIS Thermocoagulator and Digital Colposcope cleared by the FDA?

IRIS Thermocoagulator and Digital Colposcope (K202915) received a 510(k) decision of Substantially Equivalent on April 23, 2021, 206 days after the submission was received.

What is the product code of K202915?

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