Cleared Traditional

K954879 - PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)

K954879 is an FDA 510(k) clearance for PERCUTANEOUS REPLACEMENT GASTROSTOMY FE..., manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K954879 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
168d
Days
Class 2
Risk

K954879 is an FDA 510(k) clearance for the PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 168 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K954879

510(k) Number K954879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date March 29, 1996
Days to Decision 168 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
37d slower than avg
Panel avg: 131d · This submission: 168d
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 424
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K954879.
KANGAROO JEJUNAL FEEDING SYSTEM
K960677 · Sherwood Medical Co. · May 1996
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632 · Sherwood Medical Co. · May 1996
WILSON-COOK BALLOON INFLATION DEVICE
K960415 · Wilson-Cook Medical, Inc. · Apr 1996
P.E.G. PATIENT CARE KIT
K960177 · United States Endoscopy Group, Inc. · Mar 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · United States Endoscopy Group, Inc. · Jan 1996