510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253121Substantially Equivalent

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Gimbo Medical Technology Shenzhen Co., Ltd., Shezhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K253121 is the FDA 510(k) clearance record for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle, a class II device, cleared for Gimbo Medical Technology Shenzhen Co., Ltd. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 7 510(k) clearances for Gimbo Medical Technology Shenzhen Co., Ltd., from to . As of , FDA records show no recalls naming K253121.

Clearance record

Decision date
Received
(263 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gimbo Medical Technology Shenzhen Co., Ltd. 601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St., Shezhen, CN
510(k) summary
Statement
Third party review
No

Clearances, product code MQE

Trailing 12 months
1 clearance under product code MQE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260