Cleared Traditional

K920509 - URESIL SUMP DRAINAGE CATHETER

K920509 · Uresil Corp. · Gastroenterology & Urology device
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Sep 1992
Decision
223d
Days
-
Risk

K920509 is an FDA 510(k) clearance for the URESIL SUMP DRAINAGE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 223 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.

View all Uresil Corp. devices

FDA 510(k) Submission Details - K920509

510(k) Number K920509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1992
Decision Date September 14, 1992
Days to Decision 223 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 130d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 50
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K920509.
NEPHRO-URETERAL STENT
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URESIL NEPHROSTOMY CATHETER
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NEPHROSTOMY SET
K862742 · Meadox Surgimed, Inc. · Oct 1986