K240002 is an FDA 510(k) clearance for the G-Vitri™ Vitrification Straw. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024, 164 days after receiving the submission on January 2, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K240002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2024 |
| Decision Date | June 14, 2024 |
| Days to Decision | 164 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 |