Cleared Traditional

K923097 - URESIL NEPHROSTOMY CATHETER

K923097 · Uresil Corp. · Gastroenterology & Urology device

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Sep 1992

Decision

81d

Days

Risk

K923097 is an FDA 510(k) clearance for the URESIL NEPHROSTOMY 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 81 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

FDA 510(k) Submission Details - K923097

510(k) Number	K923097 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 25, 1992
Decision Date	September 14, 1992
Days to Decision	81 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

49d faster than avg

Panel avg: 130d · This submission: 81d

Pathway characteristics

Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 49

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K923097.

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

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

K891406 · Cook Urological, Inc. · Apr 1989

MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET

K850287 · Mentor Corp. · Mar 1985

MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET

K850286 · Mentor Corp. · Feb 1985

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K923097

Uresil Corp.

Skokie, IL · US

LEV MELINYSHYN

Regulatory profile

45 submissions 44 cleared

98% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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