Cleared Traditional

K961345 - DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTO...

K961345 is the FDA 510(k) clearance for DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTO... by Applied Medical Technologies. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K961345 · Applied Medical Technologies · Gastroenterology & Urology device
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Sep 1996
Decision
162d
Days
Class 2
Risk

K961345 is an FDA 510(k) clearance for the DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE. 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 September 17, 1996 after a review of 162 days - an extended review cycle.

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 Applied Medical Technologies devices

Submission Details

510(k) Number K961345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date September 17, 1996
Days to Decision 162 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 130d · This submission: 162d
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 291
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K961345.
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · United States Endoscopy Group, Inc. · Jun 1996
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248 · United States Endoscopy Group, Inc. · May 1996