← Back to catalogue

Electrosurgical Accessory

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210394

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K210394 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)

This device is an electrode, electrosurgical, active, designed for use in urological and gastroenterological procedures. It facilitates tissue ablation, coagulation, or cutting through the application of electrosurgical energy, enabling precise surgical interventions in specialized medical settings.

The Electrosurgical Accessory is supplied as a reusable medical device and is intended for use in controlled clinical environments. It is classified under FDA product code FAS as a Class II device, with FDA 510(k) clearance (K210394) through the Traditional pathway. No specific sterility or MRI safety information is provided in the data, but compliance with regulatory standards ensures safe integration into surgical workflows.

Frequently asked questions

What is the primary use of this Dornier MedTech electrosurgical accessory?

This device is an active electrosurgical electrode designed specifically for urological and gastroenterological procedures. It delivers controlled electrosurgical energy to facilitate tissue ablation, coagulation, or cutting, enabling precise surgical interventions in specialized medical settings like endoscopic or laparoscopic surgeries.

Is this device single-use or reusable, and how does that affect its use?

This electrosurgical accessory is supplied as a reusable medical device. Reusability allows for cost efficiency and reduces waste, but it requires strict adherence to manufacturer cleaning, sterilization, and maintenance protocols to ensure patient safety and device performance across multiple procedures.

What regulatory pathway was followed for FDA clearance of this device?

The device received FDA 510(k) clearance (K210394) through the Traditional pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. The Gastroenterology and Urology (GU) Advisory Committee reviewed it, confirming its safety and effectiveness for intended use in controlled clinical environments.

Are there any specific sterility or MRI safety considerations for this device?

The provided data does not specify sterility requirements or MRI safety information for this reusable electrosurgical accessory. However, compliance with general regulatory standards ensures safe integration into surgical workflows, including proper handling and maintenance to prevent contamination or interference with MRI environments.

What specialties primarily use this Dornier MedTech electrosurgical accessory?

This device is intended for use in urological and gastroenterological procedures, making it particularly relevant for specialists in those fields. Its design supports precise electrosurgical interventions, such as tissue ablation or coagulation, during endoscopic or laparoscopic surgeries commonly performed by urologists and gastroenterologists.

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: Dornier MedTech - A Leading Urological Medical Device Company, K210394 - Electrosurgical accessory | FDA 510 (k), Contact Us — Dornier MedTech, Electrosurgical accessory (K210394) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K210394 24 fields · synced Oct 6, 2026