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Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203682

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K203682 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-400 is a device classified as an electrosurgical unit (product code GEI) designed to generate high-frequency electrical energy for tissue sealing, cutting, and coagulation during surgical procedures. It incorporates a curved jaw sealer and divider with a double-action mechanism to facilitate precise tissue division and sealing in minimally invasive surgeries, particularly in general and plastic surgery applications.

This system is supplied with an ESG-400 generator and compatible foot switches, intended for use in controlled surgical environments. The POWERSEAL Curved Jaw Sealer and Divider is a single-use accessory, ensuring sterility and compliance with surgical standards. The device is authorized under FDA 510K clearance and MDR, with regulatory approvals confirming its safety and performance for electrosurgical applications. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What types of surgical procedures is the ESG-400 electrosurgical generator primarily used for, and why is the curved jaw sealer beneficial in those settings?

The ESG-400 electrosurgical generator is designed for general and plastic surgery applications, particularly in minimally invasive procedures. The POWERSEAL Curved Jaw Sealer and Divider with its double-action mechanism provides precise tissue sealing and division, which is advantageous in surgeries requiring controlled, clean cuts and hemostasis—such as in laparoscopic or endoscopic procedures where precision and reduced tissue trauma are critical.

Is the POWERSEAL Curved Jaw Sealer and Divider reusable, and if not, how should it be handled to maintain sterility?

The POWERSEAL Curved Jaw Sealer and Divider is explicitly labeled as a single-use accessory, meaning it is intended for one surgical procedure only. To maintain sterility, it should be stored in its original, sealed packaging until use and handled using standard sterile medical device protocols—such as opening the package with sterile gloves and avoiding contamination before activation.

What does the ‘double-action’ feature of the curved jaw sealer mean, and how does it improve surgical outcomes?

The ‘double-action’ mechanism refers to the sealer’s ability to perform two sequential functions: first, it seals tissue by applying controlled electrosurgical energy to create a weld-like closure, then it divides the sealed tissue with a clean cut. This reduces the risk of tissue sloughing or incomplete division, improving precision and minimizing postoperative complications like bleeding or leakage—especially valuable in delicate surgeries like plastic reconstruction or laparoscopic procedures.

How is the ESG-400 system powered, and what accessories are included in the standard supply?

The ESG-400 is an electrosurgical generator, meaning it requires connection to a standard electrical outlet for operation (specific voltage/amperage details are not provided but would follow typical medical-grade power standards). The standard supply includes the generator itself, compatible foot switches for hands-free control, and the single-use POWERSEAL Curved Jaw Sealer and Divider, ensuring all essential components for sealing, cutting, and coagulation are available out-of-the-box.

Are there specific storage requirements for the ESG-400 generator or its accessories beyond standard sterile protocols?

While the device data does not specify unusual storage conditions beyond ‘standard sterile medical device protocols,’ it’s implied that the generator should be stored in a clean, dry environment protected from physical damage or moisture (common for electrosurgical units). The single-use POWERSEAL accessory must remain in its sealed packaging until use to preserve sterility, as per surgical standards for disposable instruments.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (2)

  • FDA 510(k) K203682 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026