K250838 is an FDA 510(k) clearance for the Denudation Pipettes. This device is classified as a Microtools, Assisted Reproduction (pipettes) (Class II - Special Controls, product code MQH).
Submitted by Guangzhou Pinzhi Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 3, 2025, 105 days after receiving the submission on March 20, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6130.
| 510(k) Number | K250838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2025 |
| Decision Date | July 03, 2025 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQH - Microtools, Assisted Reproduction (pipettes) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6130 |