Arthrocare Percd Spinewand
by Arthrocare Corp. United States 510(k)
510(k) K030954 Product code GEI
Overview
The ArthroCare Perc-D SpineWand is a bipolar, single-use, high-frequency electrosurgical device classified under the product code GEI. It is designed for percutaneous procedures, specifically for ablation, coagulation, and decompression of disc material in contained herniated discs. This device operates via radiofrequency energy to target and modify tissue, aiding in the relief of symptomatic patients. Its application is focused on spinal interventions where minimally invasive techniques are preferred.
The Perc-D SpineWand is supplied as a single-use device, intended for sterile use in controlled clinical settings such as operating rooms or interventional suites. It is regulated under FDA 510(k) clearance (K030954) and falls under the Special review category for General Plastic Surgery. The device is not intended for MRI environments and must be handled according to manufacturer guidelines to ensure proper sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030954 | Date16 Apr 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from ArthroCare Corporation
Questions
What is the ArthroCare Perc-D SpineWand used for?
The Perc-D SpineWand is a bipolar, single-use electrosurgical device designed specifically for percutaneous spinal interventions. It delivers high-frequency radiofrequency energy to target and modify tissue, enabling ablation, coagulation, and decompression of contained herniated discs. This helps relieve symptoms in patients where minimally invasive techniques are preferred, such as in operating rooms or interventional suites.
How is the Perc-D SpineWand supplied and intended for use?
The device is supplied as a single-use, sterile item for controlled clinical settings like operating rooms or interventional suites. It is not intended for reuse or use in MRI environments. Proper handling and adherence to manufacturer guidelines are required to maintain sterility and functionality.
Is the Perc-D SpineWand reusable or single-use?
The Perc-D SpineWand is explicitly designed as a single-use device. This ensures sterility and safety for each procedure, reducing the risk of cross-contamination or device degradation between uses. Single-use devices are also aligned with best practices for minimally invasive spinal interventions.
What regulatory clearance does the Perc-D SpineWand hold?
The device holds FDA 510(k) clearance under the classification code GEI (General Plastic Surgery) and was granted under the Special review category. The clearance number is K030954, and it was received on April 16, 2003. No additional regulatory approvals beyond this clearance are implied.
Can the Perc-D SpineWand be used in MRI environments?
No, the Perc-D SpineWand is not intended for use in MRI environments. The device operates using radiofrequency energy, which could interfere with MRI systems or pose safety risks. Always follow manufacturer guidelines to ensure proper use and compatibility with clinical equipment.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K030954