510(k) K180429 ยท HEW Culdoscope (And Accessories)
Advincula Delineator Uterine Manipulator
| Applicant | CooperSurgical, Inc., Trumbull CT, US |
| Decision | Substantially Equivalent, Mar 14, 2018 |
| Received | Feb 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2019 | CooperSurgical, Inc. Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25
The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Lapa Terminated |
HEW | None listed |
| Jun 14, 2019 | CooperSurgical, Inc. Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30
The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Lapa Terminated |
HEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.