510(k) K160569 ยท PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
NeuGuide
| Applicant | Pop Medical Solutions, Tel Aviv, IL |
| Decision | Substantially Equivalent, Jul 6, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2021 | FEMSelect Ltd The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity.
The anchors are pre-loaded inside the device sha Open, Classified |
PBQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.