Cleared Traditional

FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT (K903325) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K903325.
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · Abbott Laboratories · Mar 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · Abbott Laboratories · Jan 1991
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · Abbott Laboratories · Nov 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · Wilson-Cook Medical, Inc. · Nov 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · Medline Industries, Inc. · Jul 1990
MAGNET RETRIEVAL CATHETER
K900852 · Cook, Inc. · May 1990