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Resection Electrodes with HF cable

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171965

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K171965 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)

Resection Electrodes with HF cable are active electrosurgical electrodes used in urological and gynecological procedures. The device consists of an active tip (loops, bands, rollers, needles, or buttons), PTFE color-coded identification, insulator, guiding tube, and shaft, and connects to an electrosurgical generator via an included HF cable.

The device is supplied as a single-use endoscopic accessory. It is classified as a Class II medical device under product code FAS and has received FDA 510(k) clearance (K171965).

Frequently asked questions

What is the intended use of the Resection Electrodes with HF cable?

The Resection Electrodes with HF cable are active electrosurgical electrodes used in urological and gynecological procedures. They consist of an active tip (loops, bands, rollers, needles, or buttons), PTFE color-coded identification, insulator, guiding tube, and shaft, and are designed to connect to an electrosurgical generator via the included HF cable for tissue resection during endoscopic procedures.

How is the Resection Electrodes with HF cable supplied and is it reusable?

The device is supplied as a single-use endoscopic accessory. It is intended for one-time use only and should not be reprocessed or reused, as it is not designed or validated for reuse, and doing so may compromise patient safety and device performance.

What regulatory pathway was used for the Resection Electrodes with HF cable, and what is its classification?

The device received FDA 510(k) clearance under submission number K171965 and is classified as a Class II medical device under product code FAS. The clearance was granted via the traditional 510(k) pathway based on a determination of substantial equivalence to a predicate device.

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 Electrodes with HF cable (K171965) - Innolitics, Resection Electrodes with HF cable (K210651) - FDA 510 (k), Resection Electrodes with HF cable 510(k) K210651 - FDA.report

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) K171965 24 fields · synced Sep 19, 2026