DWI · Saw, Electrically Powered
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | DWI |
|---|---|
| Device Name | Saw, Electrically Powered |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912237 | STRYKER ECLIPSE WARMING STRETCHER | Stryker Medical | Jul 30, 1991 | SESE |
| K801914 | TEMP STERNUM SAW | Temp Medical Products, Inc. | Oct 23, 1980 | SESE |
Top Applicants
- Temp Medical Products, Inc. — 1 clearance
- Stryker Medical — 1 clearance
