Cleared Traditional

URETERAL CATHETER AND ACCESSORIES (K934419) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K934419 · Urological Associates of Central Jersey P.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
254d
Days
Class 1
Risk

K934419 is an FDA 510(k) clearance for the URETERAL CATHETER AND ACCESSORIES. Classified as Connector, Ureteral Catheter (product code EYK), Class I - General Controls.

Submitted by Urological Associates of Central Jersey P.A. (South Plainfield, US). The FDA issued a Cleared decision on May 25, 1994 after a review of 254 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Urological Associates of Central Jersey P.A. devices

Submission Details

510(k) Number K934419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1993
Decision Date May 25, 1994
Days to Decision 254 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 130d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYK Connector, Ureteral Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.