510(k) Report

FDA product code · Gastroenterology and urology

Panendoscope (Urethroscope)

FALClass II21 CFR 876.1500510(k) required1 decision since 19770 recalls

1 FDA decision since 1977. 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 FAL 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 · FAL

FDA has decided no FAL device since 2007.

Median 510(k) review, days · FAL

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

Recalls per year · FAL

No recall names FAL since 2007.

Adverse event reports per year · FAL

2in 2019

2019: 2
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code FAL, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—02
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FAL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FAL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 876.1500.