DWH · Blade, Saw, Surgical, Cardiovascular
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | DWH |
|---|---|
| Device Name | Blade, Saw, Surgical, Cardiovascular |
| 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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904352 | CODMAN COLLINS RADIOPARENT STERNAL BLADES | Codman & Shurtleff, Inc. | Nov 21, 1990 | SESE |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | Jul 17, 1986 | SESE |
| K850483 | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | Micro-Aire Surgical Instruments, Inc. | Mar 1, 1985 | SESE |
| K830189 | CARDIOVASCULAR SAW BLADES | Temp Medical Products, Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Temp Medical Products, Inc. — 1 clearance
- Micro-Aire Surgical Instruments, Inc. — 1 clearance
- Hall Surgical, Division of Zimmer, Inc. — 1 clearance
- Codman & Shurtleff, Inc. — 1 clearance
