510(k) Report

FDA product code · Gastroenterology and urology

Cannula, A-V Shunt

FIQClass II21 CFR 876.5540510(k) required23 decisions since 19770 recalls

23 FDA decisions since 1977. 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 FIQ 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 · FIQ

FDA has decided no FIQ device since 2007.

Median 510(k) review, days · FIQ

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

Recalls per year · FIQ

No recall names FIQ since 2007.

Adverse event reports per year · FIQ

3in 2021

2007: 42008: 62018: 12019: 12020: 12021: 3
2007high 6 (2008) · low 0 (2009)2025

MAUDE reports naming product code FIQ, 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
20070—04
20080—06
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—01
20200—01
20210—03
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FIQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FIQ? 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 876.5540.