Cleared Traditional

K984310 - MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE

K984310 is an FDA 510(k) clearance for MOSS TUBES, manufactured by Moss Tubes, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984310

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 131d · This submission: 84d
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 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K984310.
MOSS GASTROSTOMY TUBE
K990389 · Moss Tubes, Inc. · Mar 1999
MODIFICATION OF MOSS P.E.G. TRAY
K984628 · Moss Tubes, Inc. · Mar 1999
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476 · Navion Biomedical Corp. · Mar 1999
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127 · Corpak Medsystems · Feb 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
TRIP TONOMETRY CATHETER, 16F
K983366 · Datex-Engstrom, Inc. · Dec 1998