K234023
- 510(k) number
- K234023
- Device name
- Oocyte Flushing & Retrieval Medium; Gamete Buffer
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2024-05-10
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K234023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.