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510(k) K180188

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish by Genea Biomedx Pty, Ltd. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2018
Date Received
January 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

Other clearances by Genea Biomedx Pty, Ltd.

  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (September 28, 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 MQG

  • K242684 — Harioculture TL-16 Time-lapse Incubator (May 22, 2025)
  • K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (May 7, 2024)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)
  • K132870 — Origio Gas Line Filter (May 7, 2014)