Cleared Traditional

K994084 - SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES

K994084 is an FDA 510(k) clearance for SMITH & NEPHEW XENON LIGHT SOURCES AND ..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K994084 · Smith & Nephew, Inc. · Gastroenterology & Urology device
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Jan 2000
Decision
48d
Days
Class 2
Risk

K994084 is an FDA 510(k) clearance for the SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 48 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K994084

510(k) Number K994084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date January 20, 2000
Days to Decision 48 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
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

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

All 12
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K994084.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · Cook Urological, Inc. · Nov 2007
ACCUTECH ENDOLITE PROBE
K061025 · Accutech Medical Technologies, Inc. · May 2006
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999
SOLARTEC SOURCE 270, MODEL # 90123
K983714 · Cogent Light Technologies, Inc. · Dec 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K982462 · Microvision, Inc. · Sep 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K980636 · Dutch Ophthalmic USA, Inc. · May 1998