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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 a medical device manufactured by Liger Medical, LLC. It received FDA 510(k) clearance on 2021-04-23 under approval 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. It is manufactured by Liger Medical, LLC. The 510(k) number is K202915.

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

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

What company makes IRIS Thermocoagulator and Digital Colposcope?

IRIS Thermocoagulator and Digital Colposcope is manufactured by Liger Medical, LLC.

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 Devices by Liger Medical, LLC

Related Devices (Code: HGI)

Official Source

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