K253121
- 510(k) number
- K253121
- Device name
- Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd. CN
- Product code
- MQE — Needle, Assisted Reproduction
- Decision date
- 2026-06-15
- Date received
- 2025-09-25
- 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: K253121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.