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Resection Electrodes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152092

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K152092 FDA 510(k)
FDA Product Code
FAS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Resection Electrodes are Electrode, Electrosurgical, Active, Urological devices, classified under FDA device class 2. These instruments are designed for electrosurgical tissue resection, delivering controlled electrical energy to cut or coagulate tissue during urological and gastroenterological procedures. They are intended for use with high-frequency electrosurgical generators and are engineered to provide precise and efficient tissue manipulation in minimally invasive surgeries.

These electrodes are supplied as reusable medical devices and are intended for use in sterile environments, such as operating rooms or endoscopic suites. They are not MRI-compatible and must be used with compatible electrosurgical equipment. The devices are available in various configurations, including loop, band, knife, and roller ball designs, to accommodate different surgical requirements. Authorized under FDA 510(k) clearance (K152092), they comply with regulatory standards outlined in 21 CFR 876.4300 and are distributed by Olympus Winter & Ibe GmbH, Hamburg, Germany.

Frequently asked questions

What are the Olympus Resection Electrodes designed for?

The Olympus Resection Electrodes are electrosurgical instruments specifically engineered for tissue resection during urological and gastroenterological procedures. They deliver controlled electrical energy to cut or coagulate tissue efficiently, making them ideal for minimally invasive surgeries where precision is critical. Their design ensures safe and effective manipulation of tissue in sterile environments like operating rooms or endoscopic suites.

Are these electrodes reusable or single-use?

The Olympus Resection Electrodes are reusable medical devices. They are intended for use in sterile environments and must be properly cleaned, sterilized, and maintained between procedures to ensure safety and performance. Reusability helps reduce waste and costs while maintaining high standards of sterility and functionality.

What types of configurations are available for these electrodes?

The Resection Electrodes come in multiple configurations to suit different surgical needs, including loop, band, knife, and roller ball designs. Each configuration is tailored for specific tissue types or surgical techniques, allowing clinicians to select the optimal tool for their procedure. This versatility supports a wide range of urological and gastroenterological applications.

Can these electrodes be used with any electrosurgical generator?

No, the Olympus Resection Electrodes must be used with compatible high-frequency electrosurgical generators. Compatibility ensures safe and effective operation, as the electrodes are designed to work seamlessly with specific systems to deliver precise electrical energy for tissue resection. Always verify compatibility with your electrosurgical equipment before use.

Are these electrodes MRI-compatible?

No, the Olympus Resection Electrodes are not MRI-compatible. They should never be used in or near an MRI environment, as the presence of metallic components could pose significant risks to both the patient and the imaging equipment. Always confirm the surgical setting and equipment compatibility before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Resection in Saline Electrodes | Olympus America | Medical, China NMPA Product Recall - High-frequency resection electrodes (HF ..., Olympus Winter and Ibe GmbH, FY24-EMEA-01, HF-resection electrode, Olympus Winter & Ibe GmbH - FDA 510 (k) Cleared Devices

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA 510(k) K152092 24 fields · synced Oct 1, 2026