FDA product code · General and plastic surgery

System, Cryosurgical, Liquid Nitrogen, For Urology

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

FAZClass 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, general and plastic surgery panel

Twenty years of FAZ 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 · FAZ

FDA has decided no FAZ device since 2007.

Median 510(k) review, days · FAZ

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

Recalls per year · FAZ

No recall names FAZ since 2007.

Adverse event reports per year · FAZ

1in 2010

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code FAZ, 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	—	0
2009	—	0
2010	—	1
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 — FAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FAZ? 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.

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