KFK · Saw, Pneumatically Powered
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | KFK |
|---|---|
| Device Name | Saw, Pneumatically 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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893949 | #157 EXAM LIGHT | Medmark, Inc. | Aug 7, 1989 | SESE |
| K894301 | MICRO-AIRE STERNUM SAW 4800 | Micro Surgical Instruments Corp. | Aug 3, 1989 | SESE |
| K870157 | OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER | Micro-Aire Surgical Instruments, Inc. | Feb 24, 1987 | SESE |
| K801737 | STERNUM SAW | Amsco Co. | Aug 20, 1980 | SESE |
Top Applicants
- Micro-Aire Surgical Instruments, Inc. — 1 clearance
- Micro Surgical Instruments Corp. — 1 clearance
- Medmark, Inc. — 1 clearance
- Amsco Co. — 1 clearance
