Cleared Traditional

K011121 - RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS (FDA 510(k) Clearance)

K011121 · Rusch Intl. · Gastroenterology & Urology device
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Nov 2001
Decision
218d
Days
-
Risk

K011121 is an FDA 510(k) clearance for the RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 218 days - an extended review 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: 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.

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Submission Details

510(k) Number K011121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2001
Decision Date November 16, 2001
Days to Decision 218 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
88d slower than avg
Panel avg: 130d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -