510(k) Report

FDA product code · Gastroenterology and urology

Prosthesis, Penis, Rigid Rod

FTQClass II21 CFR 876.3630510(k) required2 decisions since 19830 recalls

2 FDA decisions since 1983. 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 FTQ 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 · FTQ

FDA has decided no FTQ device since 2007.

Median 510(k) review, days · FTQ

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

Recalls per year · FTQ

No recall names FTQ since 2007.

Adverse event reports per year · FTQ

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2025

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

Planning a device in FTQ? 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 876.3630.