PWK
- Product code
- PWK
- Device name
- Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.4910
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Official FDA classification page: PWK
Classification and pathway per current FDA publications. Data from openFDA (CC0).