FDA product code PWJ: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
PWJ is the FDA product code for instrumentation, surgical mesh, urogynecologic, stress urinary incontinence. It is a Class II device, regulated under 21 CFR 884.4910 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under PWJ, from 3 different applicants. The average 510(k) review took 203 days (median 246).
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Classification
| Field | Value |
|---|---|
| Device name | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Device class | Class II |
| Regulation | 21 CFR 884.4910 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 117 |
| 2018 | 4 | 225 |
Compare with all 510(k) review times · Search every PWJ clearance
Top PWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 3 | 2018-08-10 |
| Caldera Medical, Inc. | 1 | 2018-05-04 |
| Boston Scientific Corporation | 1 | 2017-12-20 |
Most recent PWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181151 | ETHICON, Inc. | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | 2018-08-10 | 101 |
| K173019 | ETHICON, Inc. | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | 2018-07-06 | 281 |
| K173162 | ETHICON, Inc. | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | 2018-06-28 | 272 |
| K172614 | Caldera Medical, Inc. | 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 | 2018-05-04 | 246 |
| K172565 | Boston Scientific Corporation | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | 2017-12-20 | 117 |
Recalls for PWJ devices
openFDA lists no recalls for product code PWJ.
Frequently asked questions
What is FDA product code PWJ?
PWJ is the FDA product code for instrumentation, surgical mesh, urogynecologic, stress urinary incontinence. It is a Class II device, regulated under 21 CFR 884.4910 and reviewed by the Gastroenterology and Urology panel.
What device class is PWJ?
Class II, regulation 21 CFR 884.4910. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWJ?
Across 5 cleared submissions the average was 203 days from receipt to decision (median 246).
Which companies have the most PWJ clearances?
ETHICON, Inc. (3); Caldera Medical, Inc. (1); Boston Scientific Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PWJ
- Run a recall and safety report across every PWJ manufacturer
- Watch product code PWJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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