Cleared Special

K080944 - X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

K080944 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
203d
Days
-
Risk

K080944 is an FDA 510(k) clearance for the X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080944

510(k) Number K080944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date October 23, 2008
Days to Decision 203 days
Submission Type Special
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
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Modification to existing cleared device.

LJE Device Classification - Class 0,

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 K080944.
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
K160077 · Jbw7 Innovations, LLC · Jul 2016
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · Gyrus Acmi, Inc. · Feb 2014
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614 · Boston Scientific Corp · Sep 2012
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · C.R. Bard, Inc. · Jan 2007
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316 · C.R. Bard, Inc. · Jul 2005
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
K024050 · Cook Urological, Inc. · Feb 2003
K080944 · X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
Download PDF FDA Summary C.R. Bard, Inc.