K241454 is an FDA 510(k) clearance for the Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP). This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Guangzhou Hehong Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 3, 2025, 257 days after receiving the submission on May 22, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K241454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2024 |
| Decision Date | February 03, 2025 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQK - Labware, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6160 |