FDA product code · Neurology

Adhesive, Tissue For Aneurysmorrhaphy

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

KGFClass IIIPMA required1 decision since 19890 recalls

1 FDA decision since 1989. 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, neurology panel

Twenty years of KGF 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 · KGF

FDA has decided no KGF device since 2007.

Median 510(k) review, days · KGF

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

Recalls per year · KGF

No recall names KGF since 2007.

Adverse event reports per year · KGF

1in 2013

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code KGF, 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	—	0
2011	—	0
2012	—	0
2013	—	1
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 — KGF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KGF? 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

Adhesive, Tissue For Aneurysmorrhaphy

What has FDA decided in KGF lately?