Cleared Traditional

K063333 - M3

K063333 is an FDA 510(k) clearance for M3, manufactured by Mavig GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K063333 · Mavig GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
15d
Days
Class 2
Risk

K063333 is an FDA 510(k) clearance for the M3. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Mavig GmbH (Munchen, DE). The FDA issued a Cleared decision on November 21, 2006 after a review of 15 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 - K063333

510(k) Number K063333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date November 21, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
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 Consultant

Underwriters Laboratories, Inc.
JEFFERY D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 73
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K063333.
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ILED
K061317 · Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · Jun 2006
VISUM LED SURGICAL LIGHTING SYSTEM
K060802 · Stryker Communications Corp. · Apr 2006
OUTPATIENT III MINOR SURGERY LIGHT
K042395 · Burton Medical Products Corp. · Dec 2004

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K063333 · M3
Download PDF FDA Summary Mavig GmbH