K181034 is an FDA 510(k) clearance for the Pocket Colposcope System, a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX), submitted by Hadleigh Health Technologies, LLC (San Rafael, US). The FDA issued a Cleared decision on September 21, 2018, 156 days after receiving the submission on April 18, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K181034 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2018 |
| Decision Date | September 21, 2018 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEX — Colposcope (and Colpomicroscope) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1630 |