PWI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal 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 transvaginal pelvic organ prolapse repair
- Adverse events (MAUDE)
- 2024: 75 · 2025: 90 · 2026: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Digitex Delivery Device (K173527) | Coloplast A/S | 2018-02-12 |
| Capio SLIM Suture Capturing Device (K172060) | Boston Scientific Corporation | 2017-11-03 |
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Every clearance here is in the API, with alerts when new ones post.