Cleared Traditional

K940019 - GABRIEL URETERAL ILLUMINATOR SYSTEM

K940019 is an FDA 510(k) clearance for GABRIEL URETERAL ILLUMINATOR SYSTEM, manufactured by Gabriel Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCS cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K940019 · Gabriel Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
119d
Days
Class 2
Risk

K940019 is an FDA 510(k) clearance for the GABRIEL URETERAL ILLUMINATOR SYSTEM. Classified as Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS), Class II - Special Controls.

Submitted by Gabriel Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4020 - 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 Gabriel Medical, Inc. devices

FDA 510(k) Submission Details - K940019

510(k) Number K940019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date May 02, 1994
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCS Device Classification - Class 2, Special Controls

Product Code FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4020
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 - FCS Light, Catheter, Fiberoptic, Glass, Ureteral

Devices cleared under the same product code (FCS) and FDA review panel - the closest regulatory comparables to K940019.
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
K151243 · Stryker Endoscopy · Aug 2015
STRYKER URETERAL ILLUMINATION SYSTEM IV
K061548 · Stryker Corp. · Sep 2006
STRYKER URETERAL ILLUMINATOR SYSTEM III
K982542 · Stryker Endoscopy · Sep 1998
ILLUMINATED URETERAL CATHETER
K923436 · Cook Urological, Inc. · Mar 1993