Cleared Traditional

K983628 - XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011

K983628 is an FDA 510(k) clearance for XENON LIGHT SOURCE AUTO LIP 5123, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K983628 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
57d
Days
Class 2
Risk

K983628 is an FDA 510(k) clearance for the XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 57 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K983628

510(k) Number K983628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date December 11, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
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 28
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K983628.
LINVATEC 300W XENON LIGHT SOURCE
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K992540 · Laser Optik Systeme GmbH & Co. KG · Sep 1999
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K982962 · Contec Medical Vision, Ltd. · Sep 1998
XENON LIGHT SOURCE MODEL LS6000
K981804 · Contec Medical Vision, Ltd. · Jul 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · Welch Allyn, Inc. · Feb 1998