510(k) Report

FDA product code · Gastroenterology and urology

Telescope, Rigid, Endoscopic

FBPClass II21 CFR 876.1500510(k) required5 decisions since 19760 recalls

5 FDA decisions since 1976. 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 FBP 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 · FBP

1in 2015

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FBP

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

Recalls per year · FBP

No recall names FBP since 2007.

Adverse event reports per year · FBP

2in 2024

2007: 72008: 52009: 42010: 102011: 122012: 112013: 62020: 52023: 42024: 2
2007high 12 (2011) · low 0 (2014)2025

MAUDE reports naming product code FBP, 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—05
20090—04
20100—010
20110—012
20121—011
20130—06
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—05
20210—00
20220—00
20230—04
20240—02
20250—00
20260—0—
FIG. 1 — FBP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FBP? 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.