PWK — Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse Class II
FDA product code PWK covers "Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse", a Class II medical device regulated under 21 CFR 884.4910. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PWK
- Device Class
- Class II
- Regulation Number
- 884.4910
- Submission Type
- 510(k)
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173501 | Coloplast | Meridian Vaginal Positioning System (VPS) | Feb 9, 2018 |