Panels › General, Plastic Surgery › Product code PAH · Class 2
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Regulation 878.3300
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PAH
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems | 5 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Caldera Medical, Inc. | 2 | 0 |
| Coloplast A/S | 2 | 0 |
| Mpathy Medical Devices, Ltd. | 2 | 0 |
| Astora | 0 | 1 |
| Boston Scientific Corp | 1 | 0 |
| Coloplast Corp. | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| Gyne Ideas , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2015 | Astora MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence. Terminated |
PAH | K121641 |
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