# K122983: Ksea Bipolar Electrode

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 26, 2013 after 273 days
- Product code: HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962482 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061541: Ksea Bipolar Electrotome, Ksea (2006) Summary page 3.
- K111751: Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers, ETHICON, Inc. (2011) Summary page 3.

## Indications for use
The Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include: Excision of intrauterine myomas Excisfon of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation

Source page: https://510kreport.com/device/K122983
Methodology: https://510kreport.com/methodology