# K120418: Electrosugrical Resection and Vaporization Electrode Series

- Pathway: 510(k) (Special)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jun 20, 2012 after 131 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911904 (1991). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands, Olympus Winter & Ibe GmbH (2010) Summary page 2.

## Most influential descendants
- K221522: HF-cables (resusable) (2023), 0 descendants of its own
- K153055: ACE Electrosurgical Resection and Vaporization Electrodes Series (2016), 0 descendants of its own

## Recalls of this device
- Jun 8, 2023 · Class II · Z-2413-2023: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endosco
- Nov 3, 2016 · Class II · Z-0754-2017: Software malfunction that results in incorrect generation or display of error codes.

## Indications for use
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used for are transurethral resection in saline (TURis), transurethral prostatectomy, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used for treating cancer of the prostate. The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation,, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia 8PH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

Source page: https://510kreport.com/device/K120418
Methodology: https://510kreport.com/methodology