510(k) K183020 ยท HIH Hysteroscope (And Accessories)
Endosee System
| Applicant | CooperSurgical, Inc., Trumbull CT, US |
| Decision | Substantially Equivalent, Jan 31, 2019 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2020 | CooperSurgical, Inc. CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 Terminated |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.