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510(k) Data Aggregation
K Number
K012785Device Name
TWINTRODE ELC 134 ELECTRODE
Manufacturer
HEALTH TRONICS SURGICAL SERVICES, INC.
Date Cleared
2001-11-16
(88 days)
Product Code
LNS
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
HEALTH TRONICS SURGICAL SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.
Device Description
The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System. The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode.
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