Cleared Special

K021493 - ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S

K021493 is an FDA 510(k) clearance for ANDERSEN NASOGASTRIC TUBE WITH STYLET, manufactured by Andersen Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 113-day FDA review.

K021493 · Andersen Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
113d
Days
Class 2
Risk

K021493 is an FDA 510(k) clearance for the ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Andersen Products, Inc. (Haw River, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 113 days - within the typical 510(k) review window.

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. 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 - K021493

510(k) Number K021493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date August 30, 2002
Days to Decision 113 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
18d faster than avg
Panel avg: 131d · This submission: 113d
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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K021493.
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
K022112 · Fortune Medical Instrument Corp. · Apr 2003
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
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ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · Boston Scientific Corp · Sep 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
K021991 · Syncro Medical Innovations, Inc. · Jul 2002
INFANT FEEDING TUBES
K020005 · Promedic, Inc. · Jul 2002
K021493 · ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
Download PDF FDA Summary Andersen Products, In…