FDA product code PWI: Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
PWI is the FDA product code for instrumentation, surgical mesh, urogynecologic, transvaginal 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 2 510(k) submissions under PWI, from 2 different applicants. The average 510(k) review took 104 days (median 104). FDA has posted 13 recalls for PWI devices, 2 initiated in the last five years.
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Classification
| Field | Value |
|---|---|
| Device name | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal 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 PWI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 119 |
| 2018 | 1 | 90 |
Compare with all 510(k) review times · Search every PWI clearance
Top PWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast A/S | 1 | 2018-02-12 |
| Boston Scientific Corporation | 1 | 2017-11-03 |
Most recent PWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173527 | Coloplast A/S | Digitex Delivery Device | 2018-02-12 | 90 |
| K172060 | Boston Scientific Corporation | Capio SLIM Suture Capturing Device | 2017-11-03 | 119 |
Recalls for PWI devices
13 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-06-27.
| Year | Recalls |
|---|---|
| 2018 | 11 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code PWI?
PWI is the FDA product code for instrumentation, surgical mesh, urogynecologic, transvaginal 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 PWI?
Class II, regulation 21 CFR 884.4910. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWI?
Across 2 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most PWI clearances?
Coloplast A/S (1); Boston Scientific Corporation (1).
Have PWI devices been recalled?
Yes: 13 product recalls across 2 recall events; the most recent began 2024-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code PWI
- Run a recall and safety report across every PWI manufacturer
- Watch product code PWI 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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