510(k) K153267 · MQL Media, Reproductive
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
| Applicant | Origio A/S, Måløv, DK |
| Decision | Substantially Equivalent, Jul 22, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa
Part Number: 84051010A Open, Classified |
MQL | None listed |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060A Open, Classified |
MQL | None listed |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060D Open, Classified |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.