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510(k) K234023

Oocyte Flushing & Retrieval Medium; Gamete Buffer by Gimbo Medical Technology Shenzhen Co., Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
December 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

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

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  • K240002 — G-Vitri™ Vitrification Straw (June 14, 2024)
  • K240149 — Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst (June 13, 2024)
  • K232942 — G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media (January 30, 2024)

Other clearances for product code MQL

  • K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (February 20, 2026)
  • K250445 — Fast Warm - NX (September 12, 2025)
  • K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin (August 27, 2025)
  • K251305 — Ultra-Fast Vitri; Ultra-Fast Warm (August 26, 2025)
  • K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami (May 30, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)