K173731 is an FDA 510(k) clearance for the SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031). This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on March 2, 2018, 86 days after receiving the submission on December 6, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K173731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2017 |
| Decision Date | March 02, 2018 |
| Days to Decision | 86 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 |