Cleared Traditional

K934337 - CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE

K934337 is an FDA 510(k) clearance for CUDA PRODUCTS CORP. MODEL MX2-300 LIGHT..., manufactured by Cuda Products Co.. The device is a Class 2 General & Plastic Surgery device with product code FSW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K934337 · Cuda Products Co. · General & Plastic Surgery device
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Nov 1993
Decision
72d
Days
Class 2
Risk

K934337 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE. Classified as Light, Surgical, Endoscopic (product code FSW), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on November 18, 1993 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K934337

510(k) Number K934337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date November 18, 1993
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSW Device Classification - Class 2, Special Controls

Product Code FSW Light, Surgical, Endoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSW Light, Surgical, Endoscopic

All 7
Devices cleared under the same product code (FSW) and FDA review panel - the closest regulatory comparables to K934337.
RADLITE TISSUE RETRACTOR SYSTEM
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K943342 · M.P. Video, Inc. · Oct 1994
ILLUMINATOR IV MINOR SURGERY LIGHT
K922279 · Medical Illumination, Inc. · Sep 1992
LM-300TWIN
K913135 · Leisegang Medical, Inc. · Sep 1991
MEDICAL DYNAMICS LIGHT SOURCE
K894319 · Medical Dynamics, Inc. · Oct 1989
K934337 · CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
Download PDF Cuda Products Co.