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K Number
K013946Device Name
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
Manufacturer
AFX, INC.
Date Cleared
2002-02-27
(90 days)
Product Code
NEY, OCL
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
AFX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.
Device Description
The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Microwave Generator into the target tissue. The FLEX 10 Accessory is a sterile, hand-held, single-use, surgical ablation device. The ablative microwave energy emanates from an antenna contained in the ablation sheath at the distal end of the device.
The FLEX 10 Accessory has a flexible 2 m long insulated coax cable that attaches the Probe to the Microwave Generator output cable. The flexible cable is attached to a 24 cm long hand grip, followed by a 15 cm section of stainless steel hypotube, followed by a highly flexible PTFE ablation sheath, which contains the movable microwave energy delivery antenna. The end of the ablation sheath is attached to a PEBAX positioning sheath and sutures to aid in the proper placement of the ablating sheath. Moving the sliding ring on the hand grip moves the antenna to discrete numbered locations in the ablating sheath. The position of the antenna within the ablating sheath is displayed to the user by the position indicator of the sliding ring on the hand grip.
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K Number
K003978Device Name
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
Manufacturer
AFX, INC.
Date Cleared
2001-05-22
(151 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
AFX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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