Cleared Traditional

K910910 - MOSS- ANCHOR SET

K910910 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 KNT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K910910 · Moss Medical Products · Gastroenterology & Urology device
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Jun 1991
Decision
111d
Days
Class 2
Risk

K910910 is an FDA 510(k) clearance for the MOSS- ANCHOR SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Moss Medical Products (New York, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 111 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 Moss Medical Products devices

FDA 510(k) Submission Details - K910910

510(k) Number K910910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date June 24, 1991
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K910910.
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047 · Wilson-Cook Medical, Inc. · Sep 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · Abbott Laboratories · Aug 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · E-Z-Em, Inc. · Jul 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · Abbott Laboratories · Mar 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · Abbott Laboratories · Jan 1991
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · Biosearch Medical Products, Inc. · Dec 1990