510(k) K190639 ยท HIH Hysteroscope (And Accessories)
Endosee System
| Applicant | CooperSurgical, Inc., Trumbull CT, US |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Mar 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2019 | CooperSurgical, Inc. ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5
The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of th Terminated |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.