Cleared Traditional

K962595 - KARL STORZ XENON 300 LIGHT SOURCE FOR N...

K962595 is the FDA 510(k) clearance for KARL STORZ XENON 300 LIGHT SOURCE FOR N... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFS) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K962595 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Sep 1996
Decision
64d
Days
Class 2
Risk

K962595 is an FDA 510(k) clearance for the KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 64 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

Submission Details

510(k) Number K962595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1996
Decision Date September 04, 1996
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
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 - FFS Image, Illumination, Fiberoptic, For Endoscope

Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K962595.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · Cook Urological, Inc. · Nov 2007
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · Smith & Nephew, Inc. · Jan 2000
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440 · Welch Allyn, Inc. · Jul 1989