KDG · Chisel (Osteotome)
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | KDG |
|---|---|
| Device Name | Chisel (Osteotome) |
| 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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952678 | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | Avail-Southwest Division | Jul 10, 1995 | SESE |
| K952200 | OMNI-JUG | Waterstone Medical, Inc. | Jun 29, 1995 | SESE |
| K894785 | SURGICAL CHISEL/OSTEOTOME | Fdt Precision Machine Co., Inc. | Aug 18, 1989 | SESE |
| K891471 | SIL-MED WASTE FLUID DUMP BAG | Sil-Med Corp. | Aug 15, 1989 | SESE |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Porex Medical | Aug 21, 1987 | SESE |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Military Engineering, Inc. | Jun 23, 1987 | SESE |
| K842824 | CHERMEL BONE CHISELS | Cher Mel Corp. | Aug 2, 1984 | SESE |
| K772376 | NEIVERT OSTEOTOME | Edward Weck, Inc. | Mar 9, 1978 | SESE |
| K772374 | SILVER OSTEOTOME | Edward Weck, Inc. | Mar 9, 1978 | SESE |
| K772373 | ANDERSON-NEIVERT OSTEOTOME | Edward Weck, Inc. | Mar 9, 1978 | SESE |
| K780135 | CEMENT EXTRACTION INSTRUMENT SET | Orthopedic Equipment Co., Inc. | Jan 31, 1978 | SESE |
Top Applicants
- Edward Weck, Inc. — 3 clearances
- Avail-Southwest Division — 1 clearance
- Cher Mel Corp. — 1 clearance
- Fdt Precision Machine Co., Inc. — 1 clearance
- Military Engineering, Inc. — 1 clearance
