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510(k) K173264

EmbryoScope+ by Vitrolife A/S — Product Code MQG

K173264 is an FDA 510(k) premarket notification submitted by Vitrolife A/S for the device "EmbryoScope+". The FDA issued a decision of Substantially Equivalent on May 11, 2018. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Vitrolife A/S has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2018
Date Received
October 11, 2017
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 Vitrolife A/S

  • K213869 — EmbryoSlide+ ic8 dish (March 11, 2022)
  • K192008 — LaserShot M, NaviLase (March 25, 2020)
  • K182798 — KIDScore D3 (July 19, 2019)
  • K150961 — EmbryoSlide Culture Dish (December 4, 2015)
  • K133568 — G-TL (July 16, 2014)
  • K032154 — G-FREEZEKIT BLAST (May 7, 2004)
  • K032155 — G-THAWKIT BLAST (May 7, 2004)
  • K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION (October 27, 2003)

Other clearances for product code MQG

  • K260194 — Vacuum Pump (Model: AD-VPUM-500) (April 28, 2026)
  • 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)
  • 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)

FDA data resources