Cleared Traditional

K903086 - TUBE GASTROSTOMY

K903086 is an FDA 510(k) clearance for TUBE GASTROSTOMY, manufactured by Knight Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGC cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K903086 · Knight Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
131d
Days
Class 2
Risk

K903086 is an FDA 510(k) clearance for the TUBE GASTROSTOMY. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Knight Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 131 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.

View all Knight Medical, Inc. devices

FDA 510(k) Submission Details - K903086

510(k) Number K903086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1990
Decision Date November 20, 1990
Days to Decision 131 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
At panel average
Panel avg: 131d · This submission: 131d
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 K903086.
ONE STEP BUTTON(TM)
K910584 · Applied Medical Technologies · May 1991
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