VitriGuard— 510(k) K162833

Clearance details

Applicant

Origio A/S

Product code

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

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• 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.