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510(k) Data Aggregation
K Number
K103412Device Name
AXIOM FASCIAL CLOSURE SYSTEM
Manufacturer
AXIOM TECHNOLOGY PARTNERS, LLC
Date Cleared
2010-12-30
(38 days)
Product Code
OCW, GCJ, HCF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
AXIOM TECHNOLOGY PARTNERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axiom Fascial Closure Device is used in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Device Description
A single-use medical device used to close laparoscopic trocar site defects. Closure of laparoscopic trocar site defects is used to reduce the risk of herniation which results in adverse effects to the patient and costly surgical revision by the healthcare provider. The Axiom Fascial Closure System provides mechanical assistance to assure reliable suture placement during fascial closure procedures.
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