Cleared Traditional

K984628 - MODIFICATION OF MOSS P.E.G. TRAY (FDA 510(k) Clearance)

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

K984628 · Moss Tubes, Inc. · Gastroenterology & Urology device
Mar 1999
Decision
77d
Days
Class 2
Risk

K984628 is an FDA 510(k) clearance for the MODIFICATION OF MOSS P.E.G. TRAY. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by Moss Tubes, Inc. (Elizabeth, US). The FDA issued a Cleared decision on March 17, 1999, 77 days after receiving the submission on December 30, 1998.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K984628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1998
Decision Date March 17, 1999
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 156d · This submission: 77d
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)

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K984628.
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