Cleared Traditional

K934419 - URETERAL CATHETER AND ACCESSORIES

K934419 is an FDA 510(k) clearance for URETERAL CATHETER AND ACCESSORIES, manufactured by Urological Associates of Central Jersey P.A.. The device is a Class 1 Gastroenterology & Urology device with product code EYK cleared through the Traditional 510(k) pathway after a 254-day FDA review.

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

FDA 510(k) Submission Details - K934419

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.

EYK Device Classification - Class 1, General Controls

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.