K200680 is an FDA 510(k) clearance for the Synvitro Hyadase. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Origio A/S, A Coopersurgical Company (Måløv, DK). The FDA issued a Cleared decision on July 17, 2020, 123 days after receiving the submission on March 16, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K200680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2020 |
| Decision Date | July 17, 2020 |
| Days to Decision | 123 days |
| Submission Type | Special |
| 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 |