K203626 is an FDA 510(k) clearance for the SureStrip Vitrification Straw, SureLock Vitrification Straw. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 4, 2021, 175 days after receiving the submission on December 11, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K203626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2020 |
| Decision Date | June 04, 2021 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQK - Labware, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6160 |