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510(k) Data Aggregation
K Number
K061541Device Name
KSEA BIPOLAR ELECTROTOME
Manufacturer
KSEA
Date Cleared
2006-08-21
(77 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
KSEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KSEA Bipolar Electrotome is intended for use in combination with a resectoscope and a sheath by qualified surgeons to resect, ablate or coagulate tissue via a high frequency electrical current waveform during various endoscopic urological procedures. These procedures include bladder tumor diagnosis and resection, transurethral prostatic and bladder biopsy, transurethral prostatic resection, removal of urethral calculus, and treatment of vesical neck constriction.
Device Description
The KSEA Bipolar Electrotome is a manual surgical device, featuring a working element, a single-use cutting loop, and a high frequency cable. It is designed to be used with a 4 mm resectoscope and a 24 or 26 Fr resectoscope sheath.
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