Monopolar Cautery Cord, Bipolar Cautery Cord
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133167 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)
This device is a monopolar cautery cord and bipolar cautery cord, used in electrosurgical procedures for cutting and coagulation of tissue. It is designed for use with electrosurgical generators to deliver electrical current for tissue ablation and hemostasis.
The cord is supplied as a reusable component intended for use in general and plastic surgery settings. It received FDA 510(k) clearance under K133167 and is classified under product code GEI. The device is manufactured by Intuitive Surgical, Inc. and is not sterile, requiring appropriate cleaning and reprocessing between uses according to manufacturer instructions.
Frequently asked questions
What is the monopolar bipolar cautery cord used for?
The device is used in electrosurgical procedures for cutting and coagulation of tissue, delivering electrical current from an electrosurgical generator to achieve tissue ablation and hemostasis in general and plastic surgery settings.
Is the cautery cord sterile when supplied?
No, the cord is supplied non-sterile and must be cleaned and reprocessed according to the manufacturer's instructions before each use to ensure safe reuse in surgical procedures.
How is the cautery cord supplied and intended for use?
The cord is supplied as a reusable component designed for multiple uses after proper cleaning and reprocessing, intended for use with electrosurgical generators in general and plastic surgery environments.
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: Bipolar vs. Monopolar Electrocautery: Key Differences, PDF Intuitive Da Vinci X/Xi System Instrument and ... - Intuitive Surgical, Electrocautery Bipolar vs. Monopolar: Key differences, PDF Da Vinci SP System Instrument and Accessory Catalog - intuitive.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133167 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K133167 24 fields · synced Sep 24, 2026