510(k) Report

FDA product code · Gastroenterology and urology

Endoscope, Ac-Powered And Accessories

GCPClass II21 CFR 876.1500510(k) required13 decisions since 19772 recalls

13 FDA decisions since 1977. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K790071, named by 5 later devices.

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 GCP 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 · GCP

FDA has decided no GCP device since 2007.

Median 510(k) review, days · GCP

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

Recalls per year · GCP

1in 2024

2017: 12024: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GCP

180in 2025

2015: 42016: 132017: 1172018: 262019: 192020: 182021: 122022: 262023: 1002024: 1082025: 180
2007high 180 (2025) · low 0 (2007)2025

MAUDE reports naming product code GCP, 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—04
20160—013
20170—1117
20180—026
20190—019
20200—018
20210—012
20220—026
20230—0100
20240—1108
20250—0180
20260—0—
FIG. 1 — GCP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GCP? 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.