K181469 is an FDA 510(k) clearance for the Cryotop®US-flash and Cryotop®US-scoop. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K181469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |