Cleared Traditional

K891406 - BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

K891406 · Cook Urological, Inc. · Gastroenterology & Urology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1989

Decision

24d

Days

Risk

K891406 is an FDA 510(k) clearance for the BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 7, 1989 after a review of 24 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K891406

510(k) Number	K891406 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 1989
Decision Date	April 07, 1989
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

107d faster than avg

Panel avg: 131d · This submission: 24d

Pathway characteristics

Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 52

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K891406.

MALECOT-NEPHROSTOMY TAMPONADE CATHETER

K915209 · Cook Urological, Inc. · Nov 1992

URESIL SUMP DRAINAGE CATHETER

K920509 · Uresil Corp. · Sep 1992

URESIL NEPHROSTOMY CATHETER

K923097 · Uresil Corp. · Sep 1992

NEPHROSTOMY SET

K862742 · Meadox Surgimed, Inc. · Oct 1986

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 K891406

Cook Urological, Inc.

Spencer, IN · US

MICHELLE YOUNG

Regulatory profile

104 submissions 102 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 . FDA decision: April 7, 1989. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,972

Regulatory data since 1976

FDA monthly sync September 5, 2026