Cleared Traditional

K923488 - GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY

K923488 is an FDA 510(k) clearance for GASTRANIMAL PERCUTANEOUS REPLACEMENT GA..., manufactured by Applied Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 1100-day FDA review.

K923488 · Applied Medical Technologies · Gastroenterology & Urology device
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Jul 1995
Decision
1100d
Days
Class 2
Risk

K923488 is an FDA 510(k) clearance for the GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 1100 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 Applied Medical Technologies devices

FDA 510(k) Submission Details - K923488

510(k) Number K923488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date July 20, 1995
Days to Decision 1100 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
969d slower than avg
Panel avg: 131d · This submission: 1100d
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 489
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K923488.
ENDOLUMINAL ACCESS TUBE
K941228 · Med Institute, Inc. · Sep 1995
PRG BUTTON
K946140 · Applied Medical Technologies · Aug 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · Hollister, Inc. · Aug 1995
CORPAK GASTROSTOMY TUBE
K931921 · Corpak Co. · Jun 1995
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306 · United States Endoscopy Group, Inc. · May 1995
MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE
K945612 · Medical Innovations Corp. · Apr 1995