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Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203277

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K203277 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 Electrosurgical Generator ESG-410 is a high-frequency electrosurgical device designed for tissue resection and coagulation. It delivers controlled electrical energy to cut and seal tissue while minimizing bleeding, supporting procedures in general and plastic surgery environments. The system includes a generator unit and compatible accessories, such as foot switches and PK Cutting Forceps, to enhance precision during surgical interventions.

This device is intended for use in medical settings by qualified physicians and is supplied as a reusable system. The ESG-410 operates under FDA 510(k) clearance (K203277) and EU MDR compliance, adhering to regulatory standards for electrosurgical equipment. It is not single-use and requires proper maintenance, storage, and handling as specified in manufacturer guidelines. No MRI safety information or sterility claims are provided in the available data.

Frequently asked questions

What types of surgical procedures is the ESG-410 Electrosurgical Generator primarily used for, and why is it considered suitable for these applications?

The ESG-410 is designed for tissue resection and coagulation during surgical procedures, particularly in general and plastic surgery. It delivers controlled electrical energy to cut and seal tissue while minimizing bleeding, making it ideal for precise interventions where reducing blood loss is critical. The device’s compatibility with accessories like foot switches and PK Cutting Forceps further enhances its utility in these specialized environments.

Is the ESG-410 Electrosurgical Generator a single-use or reusable device, and what does this mean for maintenance and cost?

The ESG-410 is explicitly described as a reusable system, meaning it is built for repeated use in clinical settings. This design implies that facilities must follow manufacturer guidelines for proper maintenance, cleaning, and storage to ensure safety and functionality over time. While reusable devices may have higher upfront costs, they can reduce long-term expenses by eliminating the need for disposable alternatives.

What accessories are included with the ESG-410, and how do they contribute to its functionality during surgery?

The ESG-410 system includes compatible foot switches and PK Cutting Forceps as part of its design. Foot switches allow the surgeon to control the device hands-free, improving precision and workflow efficiency, while the PK Cutting Forceps enable controlled tissue cutting and sealing. Together, these accessories enhance the device’s versatility and precision during surgical procedures.

How should the ESG-410 be stored, and are there any specific considerations for its longevity or performance?

While the data does not specify exact storage conditions, reusable electrosurgical devices like the ESG-410 generally require protection from moisture, dust, and extreme temperatures to maintain functionality. The manufacturer’s guidelines likely outline proper cleaning, calibration, and storage protocols to ensure the device remains operational and safe for repeated use. Adhering to these instructions is essential for long-term performance and compliance with regulatory standards.

What regulatory pathways has the ESG-410 followed, and what does this mean for its use in the U.S. and European markets?

The ESG-410 has undergone FDA 510(k) clearance (K203277) and complies with EU MDR (Medical Device Regulation) standards. This means the device has been evaluated for safety and effectiveness under U.S. regulations and meets the stringent requirements for medical devices in the European Union. Clinicians and facilities can rely on these clearances to confirm the device’s regulatory compliance in their respective markets.

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: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps ..., ESG-410 Electrosurgical Generator | Bipolar Energy - Olympus, S00340EN_ESG-410_Sell-Sheet_EN_v07-1.indd - Olympus

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (2)

  • FDA 510(k) K203277 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026