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510(k) K180304

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2018
Date Received
February 2, 2018
Clearance Type
Special
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.

  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 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)
  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 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)