K181469 is an FDA 510(k) clearance for the Cryotop?US-flash and Cryotop?US-scoop, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Kitazato Corporation (Fuji-Shi, JP). The FDA issued a Cleared decision on November 9, 2018, 158 days after receiving the submission on June 4, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K181469 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 158 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 |