510(k) K954311 ยท HEW Culdoscope (And Accessories)
KOH COLPOTOMIZER SYSTEM
| Applicant | CooperSurgical, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 19, 1996 |
| Received | Sep 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2021 | CooperSurgical, Inc. The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex.
Model Number(s): KCP-30-2 Open, Classified |
HEW | None listed |
| Sep 4, 2018 | CooperSurgical, Inc. Colpo-Pneumo Occluder, Part CPO-6 Terminated |
HEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.