PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
Device Facts
| Record ID | K880150 |
|---|---|
| Device Name | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM |
| Applicant | Dyonics, Inc. |
| Product Code | HWE · General, Plastic Surgery |
| Decision Date | Mar 4, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
