VitriGuard— 510(k) K200815

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K200815 for VitriGuard, Substantially Equivalent on 2020-06-25. Applicant: Origio A/S. Device class: 2.

Clearance details

Applicant: Origio A/S
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2020-03-30
Decision date: 2020-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Måløv, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQK

K262066 — Pleiades Device2026-10-30
K262276 — Cyperus2026-10-26
K262090 — Fertilis microICSI Device2026-10-09
K241626 — SperSort Sperm Sorting Chip (IPG02)2025-02-20
K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)2025-02-03

More clearances from Origio A/S

K180740 — VitriGuard2018-05-04
K173624 — ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)2018-03-02
K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS2017-10-13
K161547 — Transem and EchoGen Embryo Transfer Catheters2017-03-09
K162833 — VitriGuard2017-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.