Cleared Traditional

K923096 - URESIL BILLIARY CATHETER

K923096 is an FDA 510(k) clearance for URESIL BILLIARY CATHETER, manufactured by Uresil Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K923096 · Uresil Corp. · Gastroenterology & Urology device
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Jul 1993
Decision
383d
Days
Class 2
Risk

K923096 is an FDA 510(k) clearance for the URESIL BILLIARY CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. 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 - K923096

510(k) Number K923096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date July 13, 1993
Days to Decision 383 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
253d slower than avg
Panel avg: 130d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 313
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K923096.
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
INTHERM STASIS VALVE SYSTEM
K931025 · Interventional Therapeutics Corp. · Sep 1993
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · Interventional Therapeutics Corp. · Oct 1992