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510(k) K253121

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle by Gimbo Medical Technology Shenzhen Co., Ltd. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2026
Date Received
September 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

Other clearances by Gimbo Medical Technology Shenzhen Co., Ltd.

  • K242043 — Sperm Freezing Medium (January 8, 2025)
  • K242968 — Giftlife® Single-Step Medium Plus (November 22, 2024)
  • K240002 — G-Vitri™ Vitrification Straw (June 14, 2024)
  • K240149 — Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst (June 13, 2024)
  • K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer (May 10, 2024)
  • K232942 — G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media (January 30, 2024)

Other clearances for product code MQE

  • K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® (November 15, 2024)
  • K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Ne (February 22, 2024)
  • K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double (November 25, 2019)
  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
  • K182959 — Wallace Dual Lumen Oocyte Recovery System (May 10, 2019)
  • K171625 — Single Lumen Ovum Aspiration Needles (January 12, 2018)
  • K171611 — Double Lumen Ovum Aspiration Needles (December 15, 2017)
  • K172050 — Follicle Aspiration Set, Reduced Single Lumen (November 21, 2017)
  • K162881 — Kitazato OPU Needles (July 11, 2017)
  • K161970 — Follicle Aspiration Set (June 14, 2017)