K250838
- 510(k) number
- K250838
- Device name
- Denudation Pipettes
- Applicant
- Guangzhou Pinzhi Medical Device Co., Ltd. CN
- Product code
- MQH — Microtools, Assisted Reproduction (Pipettes)
- Decision date
- 2025-07-03
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250838.pdf
Official FDA record: K250838
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.