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OBS Electrosurgical Generator (Model: OBS-350A)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K162034

by Baisheng Medical Co., Ltd.

Identifiers

510(k) Number
K162034 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OBS Electrosurgical Generator (Model: OBS-350A) is a device classified as an electrosurgical unit (Product Code: GEI), designed to deliver controlled electrical energy for tissue cutting, coagulation, and desiccation during surgical procedures. It operates by converting electrical power into high-frequency currents to achieve precise tissue effects, commonly used in general and plastic surgery applications.

This device is supplied as a reusable medical instrument, intended for use in operating rooms and surgical settings. It is regulated under the FDA 510(k) clearance (K162034) and complies with MDD and MDR directives, ensuring adherence to safety and performance standards. The generator requires proper maintenance, calibration, and storage in a clean, dry environment to maintain functionality and sterility of associated disposable components.

Frequently asked questions

What types of surgical procedures is the OBS-350A electrosurgical generator primarily used for?

The OBS-350A is designed for general and plastic surgery applications, delivering controlled electrical energy for tissue cutting, coagulation, and desiccation. Its high-frequency current allows precise control during procedures where these effects are required, such as excisions, tissue sealing, or cauterization.

Is the OBS-350A generator reusable, and what maintenance does it require?

Yes, the OBS-350A is a reusable medical device intended for use in operating rooms. To maintain functionality and ensure safety, it requires regular maintenance, calibration, and storage in a clean, dry environment. Associated disposable components (like electrodes) must also be handled according to sterility protocols.

How is the OBS-350A regulated, and what compliance standards does it meet?

The OBS-350A holds FDA 510(k) clearance (K162034) under the General, Plastic Surgery advisory committee, demonstrating substantial equivalence to existing devices. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring adherence to safety and performance standards in both U.S. and EU markets.

What should I consider when storing the OBS-350A to ensure its longevity and performance?

The device should be stored in a clean, dry environment to prevent damage or degradation. Since it’s reusable, proper maintenance and calibration are critical. Additionally, any disposable components used with it must be stored separately according to manufacturer guidelines to preserve sterility and functionality.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Baisheng Medical Co., Ltd.

Sources (2)

  • FDA 510(k) K162034 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026