Cleared Traditional

K900464 - MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY...

K900464 is the FDA 510(k) clearance for MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY... by Medical Innovations Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K900464 · Medical Innovations Corp. · Gastroenterology & Urology device
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Dec 1990
Decision
308d
Days
Class 2
Risk

K900464 is an FDA 510(k) clearance for the MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medical Innovations Corp. (Milpitas, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 308 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Medical Innovations Corp. devices

Submission Details

510(k) Number K900464 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 31, 1990
Decision Date December 05, 1990
Days to Decision 308 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 130d · This submission: 308d
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 212
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K900464.
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · Abbott Laboratories · Mar 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · Abbott Laboratories · Jan 1991
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · Biosearch Medical Products, Inc. · Dec 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · Abbott Laboratories · Nov 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · Abbott Laboratories · Nov 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · Wilson-Cook Medical, Inc. · Nov 1990