Sutter Electrosurgical Cables
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073450 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 Sutter Electrosurgical Cables are designed as disposable, insulated cables for use with electrosurgical units. These cables facilitate the transmission of electrical current during surgical procedures, enabling precise tissue manipulation through bipolar electrosurgery. They are categorized under the product code GEI, indicating their role in general and plastic surgery applications. Constructed with silicone material, they provide flexibility and durability for surgical environments.
These cables are intended for single-use and must be connected exclusively to the bipolar output of an approved electrosurgical unit. They are supplied sterile and packaged for clinical use in operating rooms or procedural settings. The device holds an FDA 510(k) clearance under the traditional review pathway, with a clearance date of March 17, 2008. Compliance with IEC 60601-2-2 standards is noted, though the specific PDF documentation clarifies deviations from section 46.104b of the 2007 standard.
Frequently asked questions
What are the Sutter Electrosurgical Cables used for?
The Sutter Electrosurgical Cables are designed specifically for use with bipolar electrosurgical units during surgical procedures. They transmit electrical current to enable precise tissue manipulation, making them ideal for general and plastic surgery applications where controlled coagulation and cutting are required.
Are these cables reusable or intended for single-use?
These cables are strictly for single-use only. They are packaged sterile and intended to be discarded after one surgical procedure to maintain patient safety and hygiene standards in clinical settings.
What material are the cables made from, and why does it matter?
The cables are constructed from silicone, which provides flexibility and durability in surgical environments. Silicone is also biocompatible and resistant to degradation from repeated use or exposure to surgical fluids, ensuring reliable performance during procedures.
How should these cables be stored before use?
The cables should be stored in their original, unopened sterile packaging until ready for use. This packaging protects the cables from contamination and ensures sterility. Once opened, they must be used immediately in a sterile field to prevent exposure to airborne particles or pathogens.
Can these cables be used with any electrosurgical unit?
No, these cables are designed exclusively for connection to the bipolar output of an approved electrosurgical unit. They are not compatible with monopolar outputs or non-approved devices, as this could compromise safety and performance during 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: Sutter Medizintechnik - Sutter, Zubehör | Sutter Medizintechnik - Sutter, Sutter Medical Technologies USA - Sutter, PDF 1016D_N12_ElektrochirurgieKabel
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073450 | Class II | Active |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (1)
- FDA 510(k) K073450 24 fields · synced Oct 1, 2026