Cleared Traditional

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE (K962554) - FDA 510(k) Clearance

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

K962554 · Abbott Laboratories · Gastroenterology & Urology device
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Nov 1997
Decision
494d
Days
Class 2
Risk

K962554 is an FDA 510(k) clearance for the FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY 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 November 7, 1997 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K962554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date November 07, 1997
Days to Decision 494 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
364d slower than avg
Panel avg: 130d · This submission: 494d
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)

All 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K962554.
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
KANGAROO JEJUNAL FEEDING SYSTEM
K960677 · Sherwood Medical Co. · May 1996