K242968
- 510(k) number
- K242968
- Device name
- Giftlife® Single-Step Medium Plus
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2024-11-22
- Date received
- 2024-09-26
- 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: K242968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.