Cleared Traditional

K891406 - BALLOON (NEPHROSTOMY TRACT) DILATION CA...

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

Submission Details

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
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 35
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K891406.
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
MALECOT-NEPHROSTOMY TAMPONADE CATHETER
K915209 · Cook Urological, Inc. · Nov 1992
MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
K850287 · Mentor Corp. · Mar 1985
MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET
K850286 · Mentor Corp. · Feb 1985
NEPHROSTOMY GUIDEWIRE SHEATH
K845047 · American Edwards Laboratories · Jan 1985