Arthrocare Arthrowands
by Arthrocare Corp. United States 510(k)
510(k) K072865 Product code GEI
Overview
The Arthrocare Arthrowands are bipolar, high-frequency electrosurgical devices. They are designed for use in arthroscopic and orthopedic procedures to perform soft tissue resection, ablation, coagulation, and hemostasis.
These devices are intended for single-use. This product is subject to FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072865 | Date23 Oct 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modificaton to: Arthrocare Arthrowands
- 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 are the Arthrocare Arthrowands used for?
These bipolar, high-frequency electrosurgical devices are indicated for use in orthopedic and arthroscopic procedures. They are specifically designed to perform soft tissue resection, ablation, coagulation, and hemostasis.
Are Arthrocare Arthrowands intended for single-use or reuse?
The Arthrocare Arthrowands are designed for single-use only. This requirement ensures that the device maintains its intended performance characteristics and minimizes the risk of cross-contamination between patients.
What is the regulatory status of this device?
This product is subject to FDA 510(k) clearance, identified by K-number K072865. The device was determined to be substantially equivalent to existing products for its intended use in soft tissue procedures.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K072865