Cleared Traditional

K911492 - ENDOSCOPIC LIGHT SOURCE

K911492 is the FDA 510(k) clearance for ENDOSCOPIC LIGHT SOURCE by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCT) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K911492 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
132d
Days
Class 2
Risk

K911492 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 14, 1991 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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

Submission Details

510(k) Number K911492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date August 14, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCT Light Source, Endoscope, Xenon Arc

All 15
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K911492.
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · KARL STORZ Endoscopy-America, Inc. · Apr 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · Welch Allyn, Inc. · Apr 1994
PENTAX XENON LIGHT SOURCE
K921315 · Pentax Precision Instrument Corp. · Jun 1993
PENTEX UPPER G.I. SCOPE MODEL FG-28A
K792215 · Pentax Precision Instrument Corp. · Dec 1979