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510(k) Data Aggregation
K Number
K153358Device Name
Standard Clamp
Manufacturer
STANDARD BARIATRICS
Date Cleared
2016-05-02
(164 days)
Product Code
GDJ
Regulation Number
878.4800Why did this record match?
Product Code :
GDJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.
Device Description
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
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