FDA product code · Gastroenterology and urology

System, Cryosurgical, Liquid Nitrogen, For Gastroenterology

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

NEJClass II21 CFR 878.4350510(k) required0 decisions0 recalls

0 FDA decisions. 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 NEJ 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 · NEJ

FDA has decided no NEJ device since 2007.

Median 510(k) review, days · NEJ

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

Recalls per year · NEJ

No recall names NEJ since 2007.

Adverse event reports per year · NEJ

1in 2008

2007high 1 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in NEJ? 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 878.4350.

FAZ System, Cryosurgical, Liquid Nitrogen, For…GEH Unit, Cryosurgical, Accessories