Electrocautery Cable, Bovie(tm)/Banana Plugs
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K911365 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 Electrocautery Cable, Bovie/Banana Plugs is an electrosurgical device used for cutting and coagulation. It is classified as an electrosurgical cutting and coagulation device and accessory. The device is used in medical procedures to cut and coagulate tissue.
The device is supplied as a single unit and is intended for use in a medical setting. It is classified as a Class II device with special controls. The device has been cleared by the FDA under the 510(k) clearance process, with clearance number K911365. The device is manufactured by Northgate Technologies, Inc.
Frequently asked questions
What is the Electrocautery Cable used for?
The Electrocautery Cable is used for cutting and coagulation of tissue in medical procedures.
How is the device supplied?
The device is supplied as a single unit, intended for use in a medical setting.
Is the Electrocautery Cable a single-use or reusable device?
The description does not specify if the device is single-use or reusable, but it is classified as a Class II device with special controls.
What is the regulatory status of the Electrocautery Cable?
The device has been cleared by the FDA under the 510(k) clearance process, with clearance number K911365.
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: Electrocautery Cable, Bovie (Tm)/Banana Plugs, K911365 FDA 510 (k) - ELECTROCAUTERY CABLE, PDF K911365 Electrocautery Cable, Bovie(Tm)/Banana Plugs, Northgate… — 55 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K911365 | Class II | Active |
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Manufacturer
- Manufacturer
- Northgate Technologies Inc.
- FDA Applicant
- Northgate Technologies, Inc.
Sources (1)
- FDA 510(k) K911365 24 fields · synced Sep 21, 2026