Cleared Traditional

FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT (K915110) - FDA 510(k) Clearance

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

K915110 · Abbott Laboratories · Gastroenterology & Urology device
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Apr 1992
Decision
153d
Days
Class 2
Risk

K915110 is an FDA 510(k) clearance for the FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT. 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 April 14, 1992 after a review of 153 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 Abbott Laboratories devices

Submission Details

510(k) Number K915110 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 13, 1991
Decision Date April 14, 1992
Days to Decision 153 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
23d slower than avg
Panel avg: 130d · This submission: 153d
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 K915110.
NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
K915837 · C.R. Bard, Inc. · Mar 1993
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER
K921697 · Abbott Laboratories · Aug 1992
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · Abbott Laboratories · Jun 1992
SAECG CARDIOGRAPH MODEL M1754A
K913997 · Hewlett-Packard Co. · Mar 1992
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
K914375 · Sherwood Medical Co. · Mar 1992
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · Abbott Laboratories · Nov 1991