FDA product code · Gastroenterology and urology

Lithotripter, Shockwave (For Treating Gallbladder Stones)

Name: FDA decisions, review times, recalls and adverse event reports for product code NCV
Creator: 510(k) Report

NCVClass IIIPMA required1 decision since 20000 recalls

1 FDA decision since 2000. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of NCV 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 · NCV

FDA has decided no NCV device since 2007.

Median 510(k) review, days · NCV

Too few NCV 510(k)s in any year since 2007 to give a median.

Recalls per year · NCV

No recall names NCV since 2007.

Adverse event reports per year · NCV

1in 2016

2007high 2 (2007) · low 0 (2009)2025

MAUDE reports naming product code NCV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	2
2009	—	0
2010	—	1
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — NCV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NCV? 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) Report

Lithotripter, Shockwave (For Treating Gallbladder Stones)

What has FDA decided in NCV lately?