Intuitive Surgical Vessel Sealer Extend
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183107 FDA 510(k)
- FDA Product Code
- NAY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Intuitive Surgical Vessel Sealer Extend is a bipolar electrosurgical instrument designed for grasping, blunt dissection, and bipolar coagulation of tissue. It also enables mechanical transection of vessels up to 7 mm in diameter, combining thermal sealing with mechanical cutting for precise surgical control. This device is integrated with compatible da Vinci surgical systems, leveraging robotic-assisted technology for enhanced precision in minimally invasive procedures.
Supplied as a single-use, sterile device, the Vessel Sealer Extend is intended for use in MRI-safe surgical environments when paired with the specified da Vinci systems and the ERBE VIO dV generator. It is classified under FDA 510(k) clearance (K183107) as a Class II surgical instrument, adhering to regulatory standards for computer-controlled electrosurgical systems. Storage and handling follow standard sterile medical device protocols to maintain performance and safety.
Frequently asked questions
What is the Intuitive Surgical Vessel Sealer Extend used for?
The Intuitive Surgical Vessel Sealer Extend is a bipolar electrosurgical instrument designed for robotic-assisted minimally invasive surgery. It performs grasping, blunt dissection, bipolar coagulation of tissue, and mechanical transection of vessels up to 7 mm in diameter. The device combines thermal sealing with mechanical cutting to provide precise surgical control, making it ideal for procedures requiring careful tissue management, such as those in gastroenterology or urology.
How is the Vessel Sealer Extend supplied and what is its sterility status?
The Vessel Sealer Extend is supplied as a single-use, sterile device. This ensures safety and consistency for each procedure, eliminating the need for reprocessing and reducing the risk of cross-contamination. Sterility is maintained through standard medical device manufacturing protocols, validated for use in surgical settings.
Can this device be reused, and what are the storage requirements?
No, the Vessel Sealer Extend is intended for single-use only. Reuse is not permitted as it could compromise sterility and device performance. Storage must follow standard sterile medical device protocols to preserve its integrity. Keep the device in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until use.
Which da Vinci systems and generators are compatible with this device?
The Vessel Sealer Extend is integrated with compatible da Vinci surgical systems and requires the ERBE VIO dV generator for operation. Compatibility ensures optimal performance and safety during robotic-assisted procedures. Always verify system compatibility and follow manufacturer guidelines for proper integration.
What regulatory pathway does this device follow, and what is its classification?
The Intuitive Surgical Vessel Sealer Extend follows the FDA 510(k) clearance pathway, classified as a Class II surgical instrument. It was determined to be substantially equivalent to a predicate device under the FDA’s regulatory framework for computer-controlled electrosurgical systems. The clearance number is K183107, and it adheres to regulatory standards for safety and effectiveness in surgical applications.
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: Da Vinci Vessel Sealer Extend - Intuitive Surgical, Intuitive | Maker of Da Vinci & Ion Robotic Systems, PDF Vessel Sealer Extend - Intuitive Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183107 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K183107 24 fields · synced Oct 1, 2026