Product code PWJ— Obstetrics/Gynecology
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
- Classification name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Device class
- Class 2
- Regulation
- 21 CFR 884.4910
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence”
Market context for product code PWJ
FDA has cleared devices under product code PWJ between 2017 and 2018, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
Top applicants under product code PWJ
Recent clearances under product code PWJ
- K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
- K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
- K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
- K172614 — Caldera Medical Transobturator Helical Introducer, Left +4 more
- K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.