Cleared Traditional

K962554 - FLEXIFLO LOW-PROFILE BALLOON GASTROSTOM...

K962554 is an FDA 510(k) clearance for FLEXIFLO LOW-PROFILE BALLOON GASTROSTOM..., 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 494-day FDA review.

K962554 · Abbott Laboratories · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K962554

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.

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 345
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K962554.
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
K972478 · Applied Medical Technologies · Feb 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
K973893 · Applied Medical Technologies · Dec 1997
LOW PROFILE FEEDING SET ACCESSORY
K971757 · Applied Medical Technologies · Nov 1997
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
K961345 · Applied Medical Technologies · Sep 1996