510(k) K162833 · MQK Labware, Assisted Reproduction
VitriGuard
| Applicant | Origio A/S, Måløv, DK |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | CooperSurgical, Inc. VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001
The VitriGuard device is a cryopreservation storage device composed of a stick and cap. Open, Classified |
MQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.