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510(k) Data Aggregation
K Number
K112400Device Name
SMARTSHEARS
Manufacturer
Date Cleared
2011-09-12
(24 days)
Product Code
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.
Device Description
SmartShears® is a 4-in-1 device used for the removal of bandages, splints, and clothes. The device consists of four configurations which include: the trauma shears, ruler, angle and reflex hammer.
Shears: Critical to the development of the SmartShears® for the cutting of bandages, splints or clothes
Ruler: The ruler is used for measuring the length of lacerations and the size of entrance/exit wounds, location of a fracture, and rash size.
Angle: The angle can be used to measure for angulation of bone fractures.
Reflex Hammer: The reflex hammer can be used during a reflex procedure when the cutting blades are closed for testing tendon reflexes and percussing both the abdominal and chest.
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