VitriGuard— 510(k) K180740

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K180740 for VitriGuard, Substantially Equivalent on 2018-05-04. 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: 2018-03-22
Decision date: 2018-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Måløv, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQK

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More clearances from Origio A/S

K200815 — VitriGuard2020-06-25
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.