MOQ · Battery, Replacement, Rechargeable
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | MOQ |
|---|---|
| Device Name | Battery, Replacement, Rechargeable |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081713 | VERTEBRAL ACCESS SYSTEM BY VIDACARE | Vidacare Corporation | Nov 21, 2008 | SESE |
| K013133 | NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 | Nordix, Inc. | Nov 13, 2001 | SESE |
| K980224 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 | Alexander Mfg. Co. | Apr 2, 1998 | SESE |
Top Applicants
- Vidacare Corporation — 1 clearance
- Nordix, Inc. — 1 clearance
- Alexander Mfg. Co. — 1 clearance
