Panels › Obstetrics/Gynecology › Product code PWI · Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Regulation 884.4910
0510(k)s in 12 months (2 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in PWI
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 1 | 13 |
| Coloplast A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2018 | K173527 | Digitex Delivery Device Coloplast A/S | PWI |
| Nov 3, 2017 | K172060 | Capio SLIM Suture Capturing Device Boston Scientific Corporation | PWI |
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