FDA 510(k)

IRIS Thermocoagulator and Digital Colposcope

K-Number: K202915 · 2021-04-23

Decision Date2021-04-23

Product CodeHGI

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

IRIS Thermocoagulator and Digital Colposcope is the device name listed in this FDA 510(k) record. The listed applicant is Liger Medical, LLC. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K202915. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS Thermocoagulator and Digital Colposcope?

IRIS Thermocoagulator and Digital Colposcope is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Liger Medical, LLC. The 510(k) number is K202915.

When did IRIS Thermocoagulator and Digital Colposcope receive FDA 510(k) clearance?

IRIS Thermocoagulator and Digital Colposcope received FDA 510(k) clearance on 2021-04-23, under 510(k) number K202915.

Who is the listed applicant for IRIS Thermocoagulator and Digital Colposcope?

The FDA 510(k) record lists Liger Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIS Thermocoagulator and Digital Colposcope?

The FDA product code for IRIS Thermocoagulator and Digital Colposcope is HGI.

Other records listing Liger Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152843Liger Medical HTU-110

Related Devices (Code: HGI)

K152843Liger Medical HTU-110Liger Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.