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510(k) K180740

VitriGuard by Origio A/S — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2018
Date Received
March 22, 2018
Clearance Type
Special
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 Origio A/S

  • K200815 — VitriGuard (June 25, 2020)
  • K173624 — ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phe (March 2, 2018)
  • K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (October 13, 2017)
  • K161547 — Transem and EchoGen Embryo Transfer Catheters (March 9, 2017)
  • K162833 — VitriGuard (February 16, 2017)
  • K153267 — ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Was (July 22, 2016)
  • K152932 — BlastGen (February 29, 2016)
  • K140317 — EMBRYOGEN (June 16, 2014)
  • K133912 — ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIA (May 14, 2014)
  • K132870 — Origio Gas Line Filter (May 7, 2014)

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  • 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)
  • K213869 — EmbryoSlide+ ic8 dish (March 11, 2022)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)