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510(k) K200815

VitriGuard by Origio A/S — Product Code MQK

K200815 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "VitriGuard". The FDA issued a decision of Substantially Equivalent on June 25, 2020. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Origio A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2020
Date Received
March 30, 2020
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 Origio A/S

  • K180740 — VitriGuard (May 4, 2018)
  • 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)

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

FDA data resources