FDA product code · Gastroenterology and urology
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
5 FDA decisions since 2017. No recall names this code. The most-cited predicate is K173162, named by 1 later device.
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PWJ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PWJ
4in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PWJ
259in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PWJ
No recall names PWJ since 2007.
Adverse event reports per year · PWJ
2in 2025
MAUDE reports naming product code PWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 259 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in PWJ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 884.4910.