Cleared Traditional

K961843 - GENIE

K961843 is an FDA 510(k) clearance for GENIE, 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 101-day FDA review.

K961843 · Burton Medical Products Corp. · General & Plastic Surgery device
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Aug 1996
Decision
101d
Days
Class 2
Risk

K961843 is an FDA 510(k) clearance for the GENIE. 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 August 22, 1996 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Burton Medical Products Corp. devices

FDA 510(k) Submission Details - K961843

510(k) Number K961843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date August 22, 1996
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 K961843.
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466 · Heraeus Med GmbH · Oct 1997
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997
GENIE' SINGLE CEILING AND DOUBLE CEILING
K963682 · Burton Medical Products Corp. · Nov 1996
HANAULUX BLUE 30 & 80
K954169 · Heraeus Med GmbH · Feb 1996
CHROMOPHARE
K944855 · Berchtold Holding GmbH · Oct 1994
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co. · Oct 1994