FDA product code · Cardiovascular

Tissue Graft Of Less Than 6mm

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

LWZClass IIIPathway set case by case2 decisions since 19840 recalls

2 FDA decisions since 1984. 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, cardiovascular panel

Twenty years of LWZ 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 · LWZ

FDA has decided no LWZ device since 2007.

Median 510(k) review, days · LWZ

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

Recalls per year · LWZ

No recall names LWZ since 2007.

Adverse event reports per year · LWZ

No MAUDE report names LWZ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
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 — LWZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LWZ? 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

Tissue Graft Of Less Than 6mm

What has FDA decided in LWZ lately?