Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands
510(k) K992581
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992581 | Date9 Dec 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This system comprises an electrosurgical controller, accessories, and disposable wand components designed for arthroscopic and orthopedic procedures. The Arthrocare Controller regulates energy delivery for cutting and coagulation, while the Spine Wands, Orthowands, and Arthrowands serve as single-use, sterile patient-interface tools. The Arthrocare Cable and Powercord facilitate connection between the controller and wand, and the Footswitch enables operator-controlled activation. Classified under the GEI product code, these devices are intended for use in surgical settings requiring precise electrosurgical manipulation.
The system is supplied as a sterile, single-use assembly, with wands intended for direct patient contact during arthroscopic or orthopedic procedures. The Arthrocare Controller is reusable and requires proper grounding and electrical safety compliance. No MRI safety information is specified, and devices must be stored in accordance with manufacturer instructions to maintain sterility and functionality. The system holds FDA 510(k) clearance (K992581) under the General, Plastic Surgery advisory committee, classified as substantially equivalent to predicate devices.
Other devices from ArthroCare Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Arthrocare Controller system designed for?
The Arthrocare Controller system is designed for use in arthroscopic and orthopedic surgical procedures. It regulates energy delivery for cutting and coagulation tasks, ensuring precise manipulation during surgery. The system includes disposable, sterile wands (Spine Wands, Orthowands, and Arthrowands) that are intended for direct patient contact, making it ideal for procedures requiring controlled electrosurgical tools.
Are the wands reusable or single-use?
The wands—Spine Wands, Orthowands, and Arthrowands—are explicitly designed as single-use, sterile components for direct patient contact. This ensures patient safety and sterility per manufacturer guidelines. The reusable parts of the system, such as the Arthrocare Controller, must be properly maintained and grounded for repeated use.
How should the system be stored to maintain sterility?
The system must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since the wands are single-use and sterile, they should remain in their sealed packaging until use. The reusable components, like the controller, cable, and footswitch, should be stored in a clean, dry environment away from sources of contamination or electrical hazards.
What safety considerations apply to the Arthrocare Controller?
The Arthrocare Controller requires proper grounding and adherence to electrical safety compliance standards during use. While no specific MRI safety information is provided, the device must be handled in accordance with standard surgical electrosurgical safety protocols. Always follow the manufacturer’s guidelines to avoid risks such as electrical shock or equipment malfunction.
What are the key components of the Arthrocare Controller system?
The system includes the reusable Arthrocare Controller (for energy regulation), an Arthrocare Cable and Powercord (for connecting the controller to wands), a Footswitch (for operator-controlled activation), and disposable sterile wands (Spine Wands, Orthowands, and Arthrowands) for patient contact. Each component plays a role in delivering precise electrosurgical energy during procedures.