Cleared Traditional

K913701 - MOSS - ANCHOR SET

K913701 is an FDA 510(k) clearance for MOSS - ANCHOR SET, manufactured by Moss Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K913701 · Moss Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Feb 1992
Decision
179d
Days
Class 2
Risk

K913701 is an FDA 510(k) clearance for the MOSS - ANCHOR SET. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Moss Medical Products (New York, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 179 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 Moss Medical Products devices

FDA 510(k) Submission Details - K913701

510(k) Number K913701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date February 14, 1992
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 131d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 44
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K913701.
GASTROINTESTINAL TUBE AND ACCESSORIES
K914492 · Sandoz Nutrition · Feb 1992
NASOGASTRIC FEEDING TUBE KITS
K915439 · Sandoz Nutrition · Feb 1992
FEEDING TUBE Y-PORT CONNECTOR
K915438 · Sandoz Nutrition · Feb 1992
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
EXTERNAL GASTROSTOMY TUBE RETAINER
K912575 · Sandoz Nutrition · Nov 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991