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510(k) K172197

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS by Origio A/S — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2017
Date Received
July 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Origio A/S

  • K200815 — VitriGuard (June 25, 2020)
  • K180740 — VitriGuard (May 4, 2018)
  • K173624 — ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phe (March 2, 2018)
  • 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 MQL

  • K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (February 20, 2026)
  • K250445 — Fast Warm - NX (September 12, 2025)
  • K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin (August 27, 2025)
  • K251305 — Ultra-Fast Vitri; Ultra-Fast Warm (August 26, 2025)
  • K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami (May 30, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)