Cleared Traditional

K963113 - FLEXIFLO POLYG GASTOSTOMY TUBE

K963113 is an FDA 510(k) clearance for FLEXIFLO POLYG GASTOSTOMY TUBE, 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 51-day FDA review.

K963113 · Abbott Laboratories · Gastroenterology & Urology device
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Oct 1996
Decision
51d
Days
Class 2
Risk

K963113 is an FDA 510(k) clearance for the FLEXIFLO POLYG GASTOSTOMY TUBE. 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 October 2, 1996 after a review of 51 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 - K963113

510(k) Number K963113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date October 02, 1996
Days to Decision 51 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
80d faster than avg
Panel avg: 131d · This submission: 51d
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 513
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K963113.
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087 · Sandoz Nutrition · Mar 1997
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
K950017 · Ross Products · Mar 1997
COMPAT NASOJEJUNAL FEEDING TUBE
K961664 · Sandoz Nutrition · Oct 1996
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
K961345 · Applied Medical Technologies · Sep 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
K935512 · Corpak Co. · Aug 1996