Cleared Traditional

K042034 - NUVASIVE MAXCESS LIGHT GUIDE

K042034 is the FDA 510(k) clearance for NUVASIVE MAXCESS LIGHT GUIDE by Nuvasive, Inc.. It is a Class 2 General & Plastic Surgery device (product code FST) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K042034 · Nuvasive, Inc. · General & Plastic Surgery device
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Oct 2004
Decision
89d
Days
Class 2
Risk

K042034 is an FDA 510(k) clearance for the NUVASIVE MAXCESS LIGHT GUIDE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 89 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.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K042034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date October 26, 2004
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FST Light, Surgical, Fiberoptic
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 - FST Light, Surgical, Fiberoptic

All 15
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K042034.
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K071218 · Welch Allyn, Inc. · Jun 2007
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation · Jan 2001
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K922544 · Kirschner Medical Corp. · Aug 1992
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K915274 · Pentax Precision Instrument Corp. · Jan 1992