# K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jul 1, 2010 after 150 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: 4 generations back to K911904 (1991). 17 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903323: Resectoscope Loops, Olympus Corp. (1990). Our reading of the summary gave K903233, FDA’s number for Synermed Calcium Reagent Kit (Synermed, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Resectoscope Loops”.
- K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode, Gyrus Medical, Ltd. (1999) Summary page 2.
- K030194: Xues-41 Endoscopic Electrosurgical Unit, The Olympus Optical Co. (2003) Summary page 2.
- K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode, Circon Corp. (1998) Summary page 2.
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003). Our reading of the summary gave K030185, FDA’s number for Endos AC/Acp (Villa Sistemi Medicali S.P.A.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Gyrus PlasmaKinetic Superpulse System”.

## Most influential descendants
- K152092: Resection Electrodes (2015), 5 descendants of its own
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands (2011), 5 descendants of its own
- K171965: Resection Electrodes with HF cable (2017), 3 descendants of its own
- K120567: Gyrus Amci PK Button Electrode (2012), 3 descendants of its own
- K163090: Plasma Edge System (2017), 2 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

## 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 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 to 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, culling, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUIEVP), 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/K100275
Methodology: https://510kreport.com/methodology