Panels › Obstetrics/Gynecology › Product code PBQ · Class 2
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Regulation 884.4530
1510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PBQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Escala Medical | 3 | 0 |
| Coloplast A/S | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| FEMSelect Ltd | 0 | 1 |
| Ibi Israel Biomedical Innovations , Ltd. | 1 | 0 |
| Neomedic International S.L. | 1 | 0 |
| Pop Medical Solutions | 1 | 0 |
| 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 | K160569 |
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