Cleared Traditional

Ultraxx Nephrostomy Balloon Catheter (K171601) - FDA 510(k) Clearance

K171601 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
267d
Days
-
Risk

K171601 is an FDA 510(k) clearance for the Ultraxx Nephrostomy Balloon Catheter. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 23, 2018 after a review of 267 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 K171601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date February 23, 2018
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 21
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K171601.
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Ultraxx Nephrostomy Balloon Catheter Set
K181713 · Cook Incorporated · Aug 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
K172929 · Boston Scientific Corporation · Jan 2018
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
K172527 · Cook Incorporated · Oct 2017
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614 · Boston Scientific Corp · Sep 2012