Cleared Traditional

K961345 - DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

K961345 is an FDA 510(k) clearance for DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTO..., 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 162-day FDA review.

K961345 · Applied Medical Technologies · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961345

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 131d · This submission: 162d
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 K961345.
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
K950017 · Ross Products · Mar 1997
COMPAT NASOJEJUNAL FEEDING TUBE
K961664 · Sandoz Nutrition · Oct 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
K935512 · Corpak Co. · Aug 1996
CATH CADDIE
K961884 · Mark-Clark · Aug 1996