510(k) Report

FDA product code · Gastroenterology and urology

Cord, Electric, For Endoscope

FFZClass II21 CFR 876.1500510(k) required3 decisions since 19791 recall

3 FDA decisions since 1979. 1 recall names this code; it is not Class I.

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 FFZ 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 · FFZ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFZ

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

Recalls per year · FFZ

No recall names FFZ since 2007.

Adverse event reports per year · FFZ

1in 2016

2007: 72008: 12012: 12014: 12016: 1
2007high 7 (2007) · low 0 (2009)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—01
20090—00
20100—00
20111—00
20120—01
20130—00
20140—01
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FFZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FFZ? 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

Related product codes

Other codes under 21 CFR 876.1500.