FDA product code PWK: Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
PWK is the FDA product code for instrumentation, surgical mesh, urogynecologic, transabdominal repair of pelvic organ prolapse. It is a Class II device, regulated under 21 CFR 884.4910 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under PWK. The average 510(k) review took 88 days (median 88).
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Classification
| Field | Value |
|---|---|
| Device name | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse |
| Device class | Class II |
| Regulation | 21 CFR 884.4910 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PWK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 88 |
Compare with all 510(k) review times · Search every PWK clearance
Top PWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast | 1 | 2018-02-09 |
Most recent PWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173501 | Coloplast | Meridian Vaginal Positioning System (VPS) | 2018-02-09 | 88 |
Recalls for PWK devices
openFDA lists no recalls for product code PWK.
Frequently asked questions
What is FDA product code PWK?
PWK is the FDA product code for instrumentation, surgical mesh, urogynecologic, transabdominal repair of pelvic organ prolapse. It is a Class II device, regulated under 21 CFR 884.4910 and reviewed by the Obstetrics and Gynecology panel.
What device class is PWK?
Class II, regulation 21 CFR 884.4910. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWK?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most PWK clearances?
Coloplast (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PWK
- Run a recall and safety report across every PWK manufacturer
- Watch product code PWK 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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