Cleared Special

K013144 - DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE

Also marketed or referenced as:
DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W

K013144 is an FDA 510(k) clearance for DUAL PORT WIZARD LOW PROFILE REPLACEMEN..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 29-day FDA review.

K013144 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
29d
Days
Class 2
Risk

K013144 is an FDA 510(k) clearance for the DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 19, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. 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.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K013144

510(k) Number K013144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date October 19, 2001
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K013144.
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K013162 · Medcomp · Oct 2001
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