Cleared Traditional

K963682 - GENIE' SINGLE CEILING AND DOUBLE CEILING

K963682 is an FDA 510(k) clearance for GENIE' SINGLE CEILING AND DOUBLE CEILING, manufactured by Burton Medical Products Corp.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K963682 · Burton Medical Products Corp. · General & Plastic Surgery device
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Nov 1996
Decision
71d
Days
Class 2
Risk

K963682 is an FDA 510(k) clearance for the GENIE' SINGLE CEILING AND DOUBLE CEILING. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on November 13, 1996 after a review of 71 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 Burton Medical Products Corp. devices

FDA 510(k) Submission Details - K963682

510(k) Number K963682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date November 13, 1996
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FSY Light, Surgical, Ceiling Mounted

All 48
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K963682.
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