Panels › Obstetrics/Gynecology › Product code PAI · Class 3
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation 884.5980
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PAI
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Biotech Incorporated | 1 | 0 |
| Tissue Science Laboratories, Plc | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 2013 | K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS Cook Biotech Incorporated | PAI |
| Mar 9, 2005 | K050355 | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 Tissue Science Laboratories, Plc | PAI |
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