Cleared Traditional

K915209 - MALECOT-NEPHROSTOMY TAMPONADE CATHETER

K915209 · Cook Urological, Inc. · Gastroenterology & Urology device
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Nov 1992
Decision
358d
Days
-
Risk

K915209 is an FDA 510(k) clearance for the MALECOT-NEPHROSTOMY TAMPONADE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on November 10, 1992 after a review of 358 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K915209

510(k) Number K915209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date November 10, 1992
Days to Decision 358 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
227d slower than avg
Panel avg: 131d · This submission: 358d
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 K915209.
DILATATION CATHETER, BALLOON
K952968 · Boston Scientific Corp · Aug 1995
NEPHRO-URETERAL STENT
K942688 · Uresil Corp. · Jun 1995
PERCUTANEOUS GRAINAGE CATHETER
K943893 · Menlo Care, Inc. · Mar 1995
URESIL SUMP DRAINAGE CATHETER
K920509 · Uresil Corp. · Sep 1992
URESIL NEPHROSTOMY CATHETER
K923097 · Uresil Corp. · Sep 1992
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
K891406 · Cook Urological, Inc. · Apr 1989