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Electrosurgical Generator System, Model ES 3000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052857

by Senorx, Inc.

Identifiers

510(k) Number
K052857 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 System, Model ES 3000, is a Class II medical device classified under 21 CFR 878.4400 as an electrosurgical cutting and coagulation device. It delivers controlled electrical energy to perform precise cutting and coagulation of soft tissues during surgical procedures, supporting general and plastic surgery applications.

This system is intended for use in operating room settings and is supplied as a reusable medical device. It complies with FDA 510(k) clearance (K052857) under a Special Review pathway, with no third-party certification indicated. No specific sterility or MRI safety information is provided in the regulatory data.

Frequently asked questions

What types of surgical procedures is the ES 3000 electrosurgical generator primarily designed to support in the operating room?

The ES 3000 is designed to support general and plastic surgery procedures, delivering controlled electrical energy for precise cutting and coagulation of soft tissues. Its classification under 21 CFR 878.4400 confirms its role in these surgical applications.

Is the ES 3000 electrosurgical generator reusable or single-use, and what does this mean for maintenance and usage?

The ES 3000 is supplied as a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design allows hospitals to minimize waste and costs while ensuring consistent performance across multiple procedures.

What regulatory pathway did the ES 3000 follow to achieve FDA clearance, and what does this imply about its evaluation?

The ES 3000 received FDA clearance via a 510(k) submission (K052857) under the Special Review pathway, which indicates a more rigorous evaluation than standard reviews. This pathway was used to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for electrosurgical cutting and coagulation in general and plastic surgery.

Are there any specific sterility or MRI safety considerations mentioned for the ES 3000 electrosurgical generator?

The provided regulatory data does not specify any sterility requirements for the ES 3000, implying it is not intended for sterile single-use applications. Additionally, there is no MRI safety information disclosed, meaning it should not be used in MRI environments unless verified separately by the facility.

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 System, Model Es 3000, SENORX ES-300 (K030473) — FDA 510(k) | Innolitics, PDF >4 - Food and Drug Administration, Seno Rx ES 300 Electrosurgical Generator: Includes: Cm3000 Control ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Senorx, Inc.

Sources (1)

  • FDA 510(k) K052857 24 fields · synced Sep 19, 2026