PWK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4910
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Meridian Vaginal Positioning System (VPS) (K173501) | Coloplast | 2018-02-09 |
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