Cleared Traditional

COOK NEPHROSTOMY DILATION BALLOON CATHETER SET (K024050) - FDA 510(k) Clearance

K024050 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
80d
Days
-
Risk

K024050 is an FDA 510(k) clearance for the COOK NEPHROSTOMY DILATION BALLOON CATHETER SET. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on February 27, 2003 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K024050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date February 27, 2003
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
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