Cleared Traditional

K954561 - XENON NOPPVA

K954561 is an FDA 510(k) clearance for XENON NOPPVA, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K954561 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
17d
Days
Class 2
Risk

K954561 is an FDA 510(k) clearance for the XENON NOPPVA. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 17 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K954561

510(k) Number K954561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date October 19, 1995
Days to Decision 17 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
114d faster than avg
Panel avg: 131d · This submission: 17d
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 K954561.
WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
K963227 · Products For Medicine · Oct 1996
ENDOBEAM
K963044 · Corin USA · Sep 1996
XENON LIGHTSOURCE
K962365 · Dsp Worldwide · Jul 1996
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
K952563 · The Tulip Mfg. Co. · Jul 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · Richard Wolf Medical Instruments Corp. · Jul 1995
MODEL 5135 AUTO LP/FLASH
K944607 · Richard Wolf Medical Instruments Corp. · Dec 1994