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510(k) K170498

Gems Oocyte Retrieval Buffer ORB-20, ORB-50 by Genea Biomedx Pty, Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2017
Date Received
February 17, 2017
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 Genea Biomedx Pty, Ltd.

  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K162409 — Gems Vitrification Set, Gems Warming Set (May 24, 2017)
  • K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocy (May 12, 2017)

Other clearances for product code MQL

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  • 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)