K241341 is an FDA 510(k) clearance for the cryo-GO Vitrification Device, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Fujifilm Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on September 26, 2024, 136 days after receiving the submission on May 13, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K241341 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 2024 |
| Decision Date | September 26, 2024 |
| Days to Decision | 136 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 |