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510(k) Data Aggregation
K Number
K101592Device Name
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
Manufacturer
Date Cleared
2011-10-06
(486 days)
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
CHENG MEDICAL, CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
Device Description
The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.
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