Cleared Traditional

K903325 - FLEXIFLO VERSA-PEG (TM) GASTROSTOMY KIT

K903325 is an FDA 510(k) clearance for FLEXIFLO VERSA-PEG (TM) GASTROSTOMY KIT, 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 117-day FDA review.

K903325 · Abbott Laboratories · Gastroenterology & Urology device
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Nov 1990
Decision
117d
Days
Class 2
Risk

K903325 is an FDA 510(k) clearance for the FLEXIFLO (R) VERSA-PEG (TM) 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 November 19, 1990 after a review of 117 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K903325

510(k) Number K903325 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received July 25, 1990
Decision Date November 19, 1990
Days to Decision 117 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
13d faster than avg
Panel avg: 130d · This submission: 117d
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 K903325.
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · Biosearch Medical Products, Inc. · Dec 1990
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K900464 · Medical Innovations Corp. · Dec 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · Abbott Laboratories · Nov 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · Wilson-Cook Medical, Inc. · Nov 1990
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · Delmed, Inc. · Oct 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · Delmed, Inc. · Oct 1990