# K152092: Resection Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Oct 26, 2015 after 90 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: 5 generations back to K911904 (1991). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897003: Olympus Hysteroresectoscope, Olympus Corp. (1990) Summary page 8.
- K903323: Resectoscope Loops, Olympus Corp. (1990) Summary page 8.
- K931764: HF Resection Electrode, Loop W/Runner Hyster/Acces, Olympus Corp. (1994) Summary page 8.
- K954488: Roller Electrode, Olympus America, Inc. (1997) Summary page 8.
- K931763: HF-Resection Electrode, Loop W/Runner Endos/Access, Olympus Corp. (1994) Summary page 8.
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands, Olympus Winter & Ibe GmbH (2010) Summary page 8.

## Most influential descendants
- K171965: Resection Electrodes with HF cable (2017), 3 descendants of its own
- K210651: Resection Electrodes with HF cable (2021), 1 descendant of its own
- K221893: KARL STORZ Bipolar Resectoscopes with HF Cable (2023), 0 descendants of its own
- K210394: Electrosurgical accessory (2021), 0 descendants of its own
- K161600: Resection Electrodes (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

## Indications for use
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current. General intended use Urology Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current. Gynecology 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 non-conducting irrigation fluid. The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS Specific intended use Gynecology - Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometriXP - Lysis of intrauterine septa - Endometrial ablation The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS General intended use Urology Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current. The following product is not intended to be used in urology: WA47056S Gynecology 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 non-conducting irrigation fluid. Specific intended use Gynecology - Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometriXP - Lysis of intrauterine septa - Endometrial ablation

Source page: https://510kreport.com/device/K152092
Methodology: https://510kreport.com/methodology