Cleared Traditional

K983476 - BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES

K983476 is an FDA 510(k) clearance for BIONAVIGATION SYSTEM FOR PLACEMENT OF E..., manufactured by Navion Biomedical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K983476 · Navion Biomedical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
150d
Days
Class 2
Risk

K983476 is an FDA 510(k) clearance for the BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Navion Biomedical Corp. (Stoughton, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 150 days - an extended review cycle.

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

FDA 510(k) Submission Details - K983476

510(k) Number K983476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1998
Decision Date March 01, 1999
Days to Decision 150 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
19d slower than avg
Panel avg: 131d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K983476.
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · Ross Product Div. Abbott Laboratories · Apr 1999
MOSS GASTROSTOMY TUBE
K990389 · Moss Tubes, Inc. · Mar 1999
MODIFICATION OF MOSS P.E.G. TRAY
K984628 · Moss Tubes, Inc. · Mar 1999
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
K984310 · Moss Tubes, Inc. · Feb 1999
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127 · Corpak Medsystems · Feb 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999