K232942
- 510(k) number
- K232942
- Device name
- G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2024-01-30
- Date received
- 2023-09-20
- 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: K232942
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.