Cleared Traditional

NUTRISAFE EXTENSION TUBE (K991918) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991918 · Vygon Corp. · Gastroenterology & Urology device
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Oct 1999
Decision
144d
Days
Class 2
Risk

K991918 is an FDA 510(k) clearance for the NUTRISAFE EXTENSION TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Vygon Corp. (West Cadwell, US). The FDA issued a Cleared decision on October 29, 1999 after a review of 144 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. 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 Vygon Corp. devices

Submission Details

510(k) Number K991918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1999
Decision Date October 29, 1999
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 130d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K991918.
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · Boston Scientific Corp · Jul 2002
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997