PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Class II
Classification Details
- Product Code
- PWJ
- Device Class
- Class II
- Regulation Number
- 884.4910
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181151 | ethicon | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | August 10, 2018 |
| K173019 | ethicon | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GY | July 6, 2018 |
| K173162 | ethicon | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, G | June 28, 2018 |
| K172614 | caldera medical | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transob | May 4, 2018 |
| K172565 | boston scientific corporation | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery D | December 20, 2017 |