# K210651: Resection Electrodes with HF cable

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Aug 3, 2021 after 152 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911904 (1991). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171965: Resection Electrodes with HF cable, Olympus Winter & Ibe GmbH (2017) Summary page 6.

## Most influential descendants
- K221893: KARL STORZ Bipolar Resectoscopes with HF Cable (2023), 0 descendants of its own

## Recalls of this device
- Nov 11, 2025 · Class II · Z-1449-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.

## Indications for use
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. Electrodes with HF-cable 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 conductive irrigation fluid as part of a resectoscope system. 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/K210651
Methodology: https://510kreport.com/methodology