Cleared Traditional

K981344 - URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (FDA 510(k) Clearance)

K981344 · Uresil Corp. · Gastroenterology & Urology device
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Sep 1998
Decision
154d
Days
-
Risk

K981344 is an FDA 510(k) clearance for the URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 10, 1998 after a review of 154 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 K981344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1998
Decision Date September 10, 1998
Days to Decision 154 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 130d · This submission: 154d
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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