FDA product code · Gastroenterology and urology
Stimulator, Electrical, Implantable, For Incontinence
4 FDA decisions since 1997. 7 recalls name this code, 0 of them Class I. The most-cited predicate is P970004, named by 1 later device.
PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of EZW 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 · EZW
36in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZW
Too few EZW 510(k)s in any year since 2007 to give a median.
Recalls per year · EZW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZW
6,956in 2025
MAUDE reports naming product code EZW, 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 | 6 | — | 2 | 168 |
| 2008 | 14 | — | 1 | 724 |
| 2009 | 12 | — | 0 | 1,012 |
| 2010 | 24 | — | 0 | 1,425 |
| 2011 | 26 | — | 0 | 1,610 |
| 2012 | 19 | — | 0 | 2,815 |
| 2013 | 17 | — | 0 | 3,736 |
| 2014 | 23 | — | 0 | 4,603 |
| 2015 | 20 | — | 0 | 5,977 |
| 2016 | 27 | — | 0 | 7,083 |
| 2017 | 27 | — | 0 | 8,097 |
| 2018 | 19 | — | 0 | 5,737 |
| 2019 | 24 | — | 0 | 4,772 |
| 2020 | 43 | — | 0 | 4,118 |
| 2021 | 34 | — | 1 | 4,479 |
| 2022 | 46 | — | 1 | 4,318 |
| 2023 | 32 | — | 0 | 5,056 |
| 2024 | 35 | — | 1 | 5,773 |
| 2025 | 36 | — | 0 | 6,956 |
| 2026 | 37 | — | 1 | — |
Planning a device in EZW? 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 876.5270.