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510(k) Data Aggregation
K Number
K171024Device Name
ShockPulse-SE Lithotripsy System
Manufacturer
Cybersonics, Inc.
Date Cleared
2017-08-21
(138 days)
Product Code
FEO
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
Cybersonics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Device Description
The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.
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K Number
K142428Device Name
Shock Pulse-SE Lithotripsy System CYBERWAND II
Manufacturer
CYBERSONICS, INC.
Date Cleared
2014-11-13
(76 days)
Product Code
FEO
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calcul in the kidney, ureter and bladder.
Device Description
The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. The ShockPulse-SE is an electromechanical device, whose intended purpose is to fragment and aspirate calculi. The hand piece consists of an ultrasonic transducer containing piezoelectric elements which are driven by a generator operating at approximately 21,000 Hz. The transducer is lightweight and incorporates two contact switches that activate Standard Power and High Power generator output. Activation will either require continuous pushing of the button or a double click to latch activation on; a single click of either button would then turn activation off. There are markings near the buttons to indicate function. Suction control is integrated into the transducer housing. With a thumb wheel that can rotate approximately 20 degrees, the flow can be varied from "full" on to "off." There are markings on the transducer to indicate which direction increases and decreases suction flow through the transducer lumen. There are families of probes that function similar to the probes of the current CyberWand System (K120303) by transmitting stress-waves from the transducer to the calculi to break up kidney-stones. Hollow probes permit simultaneous suction. The direct patient-contact material is stainless steel, which is the same material used in the predicate system.
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K Number
K132795Device Name
CYBERWAND STERILE PROBE SET
Manufacturer
CYBERSONICS, INC.
Date Cleared
2013-11-26
(81 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
Device Description
The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements. which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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K Number
K120303Device Name
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
Manufacturer
CYBERSONICS, INC.
Date Cleared
2012-06-05
(125 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Device Description
The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer (2), Footswitch, Power Cord, Wrench, and Cleaning Stylet. The disposable probe set is sold separately either sterile or non-sterile. The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements, which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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K Number
K102169Device Name
CYBERWAND LITHOTRIPTER
Manufacturer
CYBERSONICS, INC.
Date Cleared
2010-08-30
(28 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
Device Description
The CyberWand Dual Ultrasonic Lithotripsy System is an electromechanical device used to fragment and aspirate calculi. The system consists of the generator unit, transducer handpiece, footswitch, probe sets and cleaning stylets.
The Semi-Flexible Probe is constructed entirely of stainless steel and is packaged with a stainless steel cleaning stylet. The probe has a working length of 58.5 cm and an outer diameter of 1.65 mm; it is is intended to be used primarily with semi-rigid or ridged scopes (cystoscopes, nephroscopes and ureteroscopes) which have a working channel between 5 and 7 French in diameter.
The probe is for provided non-sterile and is for single-patient use.
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K Number
K072422Device Name
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
Manufacturer
CYBERSONICS, INC.
Date Cleared
2007-10-24
(57 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CyberWand™ Lithotripter with STERILE Probes is intended to be used for the intracorporeal fragmentation of urinary tract calculi in the kidney, ureter, bladder and biliary tracts.
Device Description
Not Found
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K Number
K052135Device Name
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
Manufacturer
CYBERSONICS, INC.
Date Cleared
2005-12-20
(137 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
CYBERSONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Device Description
The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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