# K061541: Ksea Bipolar Electrotome

- Pathway: 510(k) (Traditional)
- Applicant: Ksea
- Decided: Aug 21, 2006 after 77 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122983: Ksea Bipolar Electrode (2013), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K061541
Methodology: https://510kreport.com/methodology