FDA product code · Gastroenterology and urology

Enteroscope And Accessories

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

FDAClass II21 CFR 876.1500510(k) required20 decisions since 19810 recalls

20 FDA decisions since 1981. 510(k) reviews decided 2021–2025 took a median of 115 days (half between 77 and 161). No recall names this code. The most-cited predicate is K040048, named by 10 later devices.

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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 FDA 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 · FDA

1in 2025

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDA

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

Recalls per year · FDA

No recall names FDA since 2007.

Adverse event reports per year · FDA

116in 2025

2007high 116 (2025) · low 0 (2011)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	1
2008	1	—	1
2009	0	—	3
2010	0	—	1
2011	0	—	0
2012	0	—	2
2013	0	—	2
2014	0	—	3
2015	1	—	2
2016	0	—	5
2017	0	—	28
2018	0	—	81
2019	2	—	76
2020	1	—	29
2021	1	—	24
2022	0	—	87
2023	2	—	72
2024	1	—	86
2025	1	—	116
2026	1	—	—

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

Planning a device in FDA? 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.

FAL Panendoscope (Urethroscope)FBO Cystourethroscope NWB Endoscope, Accessories, Narrow Band Spectrum KGD Scissors For Cystoscope FCZ Tube, Smoke Removal, Endoscopic FDW Esophagoscope, Rigid, Gastro-Urology FGS Carrier, Sponge, Endoscopic GCM Endoscope, Rigid GCN Endoscope, Prism FGA Kit, Nephroscope FAM Sigmoidoscope And Accessories, Flexible/Rigid GDB Endoscope, Fiber Optic

Enteroscope And Accessories

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