Cleared Traditional

K942688 - NEPHRO-URETERAL STENT

K942688 · Uresil Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
364d
Days
-
Risk

K942688 is an FDA 510(k) clearance for the NEPHRO-URETERAL STENT. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on June 6, 1995 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K942688

510(k) Number K942688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date June 06, 1995
Days to Decision 364 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
234d slower than avg
Panel avg: 130d · This submission: 364d
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 K942688.
MANAN NEPHROSTOMY DRAINAGE CATHETER
K953547 · Manan Medical Products, Inc. · Aug 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K952887 · Meadox Medicals, Div. Boston Scientific Corp. · Aug 1995
DILATATION CATHETER, BALLOON
K952968 · Boston Scientific Corp · Aug 1995
PERCUTANEOUS GRAINAGE CATHETER
K943893 · Menlo Care, Inc. · Mar 1995
MALECOT-NEPHROSTOMY TAMPONADE CATHETER
K915209 · Cook Urological, Inc. · Nov 1992
URESIL SUMP DRAINAGE CATHETER
K920509 · Uresil Corp. · Sep 1992