Cleared Traditional

CIRCLE NEPHROSTOMY CATHETER SET (K961933) - FDA 510(k) Clearance

K961933 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
62d
Days
-
Risk

K961933 is an FDA 510(k) clearance for the CIRCLE NEPHROSTOMY CATHETER SET. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 62 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 K961933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date July 18, 1996
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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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