Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle— 510(k) K253121
Substantially EquivalentGimbo Medical Technology Shenzhen Co., Ltd.
FDA 510(k) clearance K253121 for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle, Substantially Equivalent on 2026-06-15. Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.. Device class: 2.
Summary
Gimbo Medical Technology Shenzhen's clearance covers two Giftlife oocyte retrieval needles, one single lumen and one double lumen. They're filed under MQE, assisted reproduction needles, and the record gives no gauges or lengths.
Class II, 21 CFR 884.6100. Obstetrics/Gynecology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Gimbo filed from Shezhen, China, as the record spells the city. Review took 263 calendar days (September 25, 2025 to June 15, 2026).
Clearance details
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd.
- Product code
- Product code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shezhen, CN
Recent devices under product code MQE
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- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K182959 — Wallace Dual Lumen Oocyte Recovery System
More clearances from Gimbo Medical Technology Shenzhen Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.