Cleared Traditional

URESIL NEPHRO-URETERAL STENT (K980889) - FDA 510(k) Clearance

K980889 · Uresil Corp. · Gastroenterology & Urology device
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Apr 1998
Decision
30d
Days
-
Risk

K980889 is an FDA 510(k) clearance for the URESIL NEPHRO-URETERAL STENT. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on April 8, 1998 after a review of 30 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 Uresil Corp. devices

Submission Details

510(k) Number K980889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date April 08, 1998
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 18
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K980889.
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DILATATION CATHETER, BALLOON
K952968 · Boston Scientific Corp · Aug 1995