K202915 is an FDA 510(k) clearance for the IRIS Thermocoagulator and Digital Colposcope. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Liger Medical, LLC (Lehi, US). The FDA issued a Cleared decision on April 23, 2021, 206 days after receiving the submission on September 29, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K202915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | April 23, 2021 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGI - Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4120 |