Cleared Traditional

K901791 - PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.

K901791 is an FDA 510(k) clearance for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEE..., manufactured by Southside Biotechnology. The device is a Class 2 Gastroenterology & Urology device with product code KGC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K901791 · Southside Biotechnology · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
111d
Days
Class 2
Risk

K901791 is an FDA 510(k) clearance for the PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Southside Biotechnology (Willoughby Hills, US). The FDA issued a Cleared decision on August 8, 1990 after a review of 111 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K901791

510(k) Number K901791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 19, 1990
Decision Date August 08, 1990
Days to Decision 111 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
20d faster than avg
Panel avg: 131d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGC Device Classification - Class 2, Special Controls

Product Code KGC Tube, Gastro-enterostomy
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 - KGC Tube, Gastro-enterostomy

All 20
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K901791.
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779 · C.R. Bard, Inc. · Jan 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K904801 · Orion Life Systems, Inc. · Jan 1991
P.R.G. GUIDEWIRE PLACEMENT SYSTEM
K903036 · Applied Medical Technologies · Nov 1990
P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY
K900884 · Applied Medical Technologies · Jul 1990
CORPAK GASTROSTOMY TUBE
K901501 · Corpak Co. · Jun 1990
CENTRAL CATHETER TRAY
K781333 · Argon Medical Corp. · Oct 1978