510(k) Report

FDA product code · Neurology

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

KGGClass IIIPMA required1 decision since 20002 recalls

1 FDA decision since 2000. 2 recalls name this code, 2 of them Class I.

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 KGG 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 · KGG

2in 2025

2007: 22009: 32010: 62011: 12013: 12014: 12015: 22016: 22017: 22018: 22019: 22023: 22024: 22025: 22026 (partial year): 2
2007high 6 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGG

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

Recalls per year · KGG

2in 2013

2013: 2, 2 Class I
2007high 2 (2013) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · KGG

16in 2025

2008: 12011: 12012: 92013: 32016: 32017: 102019: 72020: 122021: 102022: 52023: 72024: 62025: 16
2007high 16 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—01
20093—00
20106—00
20111—01
20120—09
20131—2 (2)3
20141—00
20152—00
20162—03
20172—010
20182—00
20192—07
20200—012
20210—010
20220—05
20232—07
20242—06
20252—016
20262—0—
FIG. 1 — KGG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KGG? 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