510(k) Report

FDA product code · Gastroenterology and urology

Cord, Electric For Transurethral Surgical Instrument

FBJClass II21 CFR 876.4300510(k) required0 decisions0 recalls

0 FDA decisions. 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 FBJ 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 · FBJ

FDA has decided no FBJ device since 2007.

Median 510(k) review, days · FBJ

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

Recalls per year · FBJ

No recall names FBJ since 2007.

Adverse event reports per year · FBJ

1in 2025

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

MAUDE reports naming product code FBJ, 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—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — FBJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FBJ? 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 876.4300.