Cleared Traditional

K910332 - FLEXIFLO SACKS-VINE GASTROSTOMY KITS

K910332 is an FDA 510(k) clearance for FLEXIFLO SACKS-VINE GASTROSTOMY KITS, manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K910332 · Abbott Laboratories · Gastroenterology & Urology device
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Mar 1991
Decision
53d
Days
Class 2
Risk

K910332 is an FDA 510(k) clearance for the FLEXIFLO SACKS-VINE GASTROSTOMY KITS. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 53 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K910332

510(k) Number K910332 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 25, 1991
Decision Date March 19, 1991
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
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 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K910332.
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 STOMATE EXTENSION TUBE
K902623 · Abbott Laboratories · Jan 1991
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · Biosearch Medical Products, Inc. · Dec 1990
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K900464 · Medical Innovations Corp. · Dec 1990