Cleared Traditional

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051) - FDA 510(k) Clearance

K183051 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
256d
Days
-
Risk

K183051 is an FDA 510(k) clearance for the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 16, 2019 after a review of 256 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Incorporated devices

Submission Details

510(k) Number K183051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 02, 2018
Decision Date July 16, 2019
Days to Decision 256 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 130d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K183051.
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