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510(k) K240149

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium by Gimbo Medical Technology Shenzhen Co., Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
January 19, 2024
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.

  • K242043 — Sperm Freezing Medium (January 8, 2025)
  • K242968 — Giftlife® Single-Step Medium Plus (November 22, 2024)
  • K240002 — G-Vitri™ Vitrification Straw (June 14, 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 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)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (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)