Home / 510(k) Clearances / K213869

510(k) K213869

EmbryoSlide+ ic8 dish by Vitrolife A/S — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
December 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Vitrolife A/S

  • K192008 — LaserShot M, NaviLase (March 25, 2020)
  • K182798 — KIDScore D3 (July 19, 2019)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • 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 MQK

  • K241626 — SperSort™ Sperm Sorting Chip (IPG02) (February 20, 2025)
  • K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT (February 3, 2025)
  • K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (January 31, 2025)
  • K241341 — cryo-GO Vitrification Device (September 26, 2024)
  • K240002 — G-Vitri™ Vitrification Straw (June 14, 2024)
  • K232980 — SpermAlign Sperm Separation Device (March 14, 2024)
  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (October 31, 2022)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)
  • K201213 — Pasteur Pipette 3mL, Pasteur Pipette 1mL (December 16, 2020)