NEEDLE DRIVER
Device Facts
| Record ID | K780255 |
|---|---|
| Device Name | NEEDLE DRIVER |
| Applicant | Scanlan Intl., Inc. |
| Product Code | GFC · General, Plastic Surgery |
| Decision Date | Apr 18, 1978 |
| 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.
