Cleared Traditional

K921390 - XENON LIGHT SOURCE AND ACCESSORIES

K921390 is an FDA 510(k) clearance for XENON LIGHT SOURCE AND ACCESSORIES, manufactured by Coopervision Surgical. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K921390 · Coopervision Surgical · Gastroenterology & Urology device
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Jul 1992
Decision
126d
Days
Class 2
Risk

K921390 is an FDA 510(k) clearance for the XENON LIGHT SOURCE AND ACCESSORIES. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Coopervision Surgical (Shelton, US). The FDA issued a Cleared decision on July 27, 1992 after a review of 126 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 Coopervision Surgical devices

FDA 510(k) Submission Details - K921390

510(k) Number K921390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date July 27, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 130d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K921390.
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · Medical Devices, Inc. · Jul 1993
PENTAX XENON LIGHT SOURCE
K921315 · Pentax Precision Instrument Corp. · Jun 1993
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · Cabot Medical Corp. · Oct 1992
MARLOW VERRES NEEDLES
K913586 · Marlo Surgical Technology · Oct 1991
ENDOSCOPIC LIGHT SOURCE
K911492 · United States Endoscopy Group, Inc. · Aug 1991
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801 · Keymed, Inc. · Dec 1986