Cleared Traditional

K963227 - WHITE SUN LIGHT SOURCE MODEL #: XL300 A...

K963227 is an FDA 510(k) clearance for WHITE SUN LIGHT SOURCE MODEL #: XL300 A..., manufactured by Products For Medicine. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K963227 · Products For Medicine · Gastroenterology & Urology device
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Oct 1996
Decision
65d
Days
Class 2
Risk

K963227 is an FDA 510(k) clearance for the WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Products For Medicine (La Quinta, US). The FDA issued a Cleared decision on October 23, 1996 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Products For Medicine devices

FDA 510(k) Submission Details - K963227

510(k) Number K963227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date October 23, 1996
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
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 K963227.
LUMENON XENON LIGHT SOURCE
K992050 · Walter Lorenz Surgical, Inc. · Sep 1999
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · Welch Allyn, Inc. · Feb 1998
ENDOBEAM
K963044 · Corin USA · Sep 1996
XENON NOPPVA
K954561 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · Richard Wolf Medical Instruments Corp. · Jul 1995