# K161600: Resection Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Sep 6, 2016 after 89 days
- Product code: JOS (Electrode, Electrosurgical)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911904 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152092: Resection Electrodes, Olympus Winter & Ibe GmbH (2015) Summary page 4.

## Indications for use
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in saline irrigation fluid. Specific indications: - transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - endometrial ablation

Source page: https://510kreport.com/device/K161600
Methodology: https://510kreport.com/methodology