K192644 is an FDA 510(k) clearance for the GM501 SpermAir and GM501 SpermActive. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Hamilton Thorne Incorporated (Beverly, US). The FDA issued a Cleared decision on April 23, 2020, 212 days after receiving the submission on September 24, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K192644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | April 23, 2020 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL - Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |