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510(k) K133912

ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO by Origio A/S — Product Code MQL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 14, 2014
Date Received: December 23, 2013
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)
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)
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)