# PWJ: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

- Device class: 2; regulation: 21 CFR 884.4910; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 4

## Most-cited predicates
- K173162: GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide (2018), cited by 1
- K173019: GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (2018), cited by 1
- K181151: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (2018), cited by 1
- K172614: Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left (2018), cited by 1

Source page: https://510kreport.com/product-code/PWJ
Data by year (CSV): https://510kreport.com/product-code/PWJ.csv