FDA product code · Gastroenterology and urology

Laparoscopy Kit

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

FDEClass II21 CFR 876.15004 decisions since 199154 recalls

4 FDA decisions since 1991. 54 recalls name this code, 19 of them Class I. The most-cited predicate is K942677, named by 2 later devices.

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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 FDE 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 · FDE

FDA has decided no FDE device since 2007.

Median 510(k) review, days · FDE

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

Recalls per year · FDE

3in 2025

2007high 18 (2014) · low 0 (2007)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FDE

17in 2025

2007high 56 (2024) · low 0 (2010)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	5
2008	—	0	7
2009	—	0	5
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	18 (18)	0
2015	—	0	0
2016	—	0	4
2017	—	0	14
2018	—	0	8
2019	—	0	12
2020	—	1	14
2021	—	0	18
2022	—	5	17
2023	—	4	23
2024	—	7	56
2025	—	3 (1)	17
2026	—	16	—

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

Planning a device in FDE? 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

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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

Laparoscopy Kit

Which predicates do FDE devices cite most?

Which FDE devices have the deepest lineage?

What has FDA decided in FDE lately?

What has been recalled in FDE lately?

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