VitriGuard— 510(k) K162833

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K162833 for VitriGuard, Substantially Equivalent on 2017-02-16. 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: 2016-10-11
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Måløv, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Origio A/S

K200815 — VitriGuard2020-06-25
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

Recalls naming K162833

K-number listed on FDA's recall record

Z-1108-2022 — VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.Class II·Ongoing·CooperSurgical, Inc.·20220401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162833.

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