Identifiers
- 510(k) Number
- K081678 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 CONMED Beamer System C600 is an electrosurgical device designed for cutting and coagulation procedures. It features built-in intelligence and an intuitive user interface to allow for quick selection of desired clinical effects.
The system is supplied by KLS Martin GmbH + Co. KG and is intended for use in general and plastic surgery. It received FDA 510(k) clearance with product code GEI on July 29, 2008, and is classified under regulation 878.4400.
Frequently asked questions
What is the CONMED Beamer System C600 used for?
The CONMED Beamer System C600 is an electrosurgical device designed for cutting and coagulation procedures in general and plastic surgery. It features built-in intelligence and an intuitive user interface to allow for quick selection of desired clinical effects.
How is the CONMED Beamer System C600 supplied?
The system is supplied by KLS Martin GmbH + Co. KG. The device is intended for use in general and plastic surgery procedures, providing clinicians with a reliable electrosurgical solution for cutting and coagulation.
What regulatory approvals does the CONMED Beamer System C600 have?
The CONMED Beamer System C600 received FDA 510(k) clearance with product code GEI on July 29, 2008. It is classified under regulation 878.4400 and was determined to be substantially equivalent to predicate devices.
What are the key features of the CONMED Beamer System C600?
The system features built-in intelligence and an intuitive user interface to allow for quick selection of desired clinical effects. These features are designed to enhance usability during cutting and coagulation procedures in general and plastic surgery.
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: CONMED BEAMER SYSTEM C600 (K081678) — FDA 510(k) | Innolitics, CONMED BEAMER SYSTEM C600 510(k) K081678 - FDA.report, Beamer ESU | CONMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081678 | Class II | Active |
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Manufacturer
- Manufacturer
- KLS Martin GmbH + Co. KG
Sources (1)
- FDA 510(k) K081678 24 fields · synced Sep 21, 2026