Cleared Special

K063632 - X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER

K063632 · 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
Jan 2007
Decision
30d
Days
-
Risk

K063632 is an FDA 510(k) clearance for the X-FORCE N30 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 January 5, 2007 after a review of 30 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K063632

510(k) Number K063632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2006
Decision Date January 05, 2007
Days to Decision 30 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
101d faster than avg
Panel avg: 131d · This submission: 30d
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 K063632.
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K080944 · C.R. Bard, Inc. · Oct 2008
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K024050 · Cook Urological, Inc. · Feb 2003
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · Rusch Intl. · Nov 2001
K063632 · X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
Download PDF FDA Summary C.R. Bard, Inc.