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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.

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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance,
sample sizes, expert qualifications, adjudication methods, MRMC studies,
standalone performance, ground truth types, or training set details. This document is a 510(k) summary
for a medical device (KSEA Bipolar Electrotome) and primarily
discusses its intended use, description, and substantial equivalence to
predicate devices, as well as the FDA's clearance letter. It does not
contain the kind of detailed study data or performance metrics you are
requesting.

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