Cleared Traditional

K984310 - MOSS TUBES

K984310 is the FDA 510(k) clearance for MOSS TUBES by Moss Tubes, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K984310 · Moss Tubes, Inc. · Gastroenterology & Urology device
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Feb 1999
Decision
84d
Days
Class 2
Risk

K984310 is an FDA 510(k) clearance for the MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Moss Tubes, Inc. (Elizabeth, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Moss Tubes, Inc. devices

Submission Details

510(k) Number K984310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date February 24, 1999
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 253
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K984310.
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K981203 · Rusch Intl. · Jun 1998
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K973892 · Rusch Intl. · May 1998