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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Assisted Reproduction
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.
601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St.
Guangming District
Shezhen,  CN 518107
Applicant Contact Guo Leo
Correspondent
Gimbo Medical Technology Shenzhen Co., Ltd.
601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St.
Guangming District
Shezhen,  CN 518107
Correspondent Contact Guo Leo
Regulation Number884.6100
Classification Product Code
MQE  
Date Received09/25/2025
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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