GFD · Dermatome
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | GFD |
|---|---|
| Device Name | Dermatome |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965256 | DMS-1000C DERMOABRADER | Mattioli Engineering, Srl | Dec 9, 1996 | SESE |
| K962371 | DERMTOME BLADE | Dsp Worldwide | Aug 29, 1996 | SESE |
| K945594 | DECA DERMATOME (MICROMOTOR SYSTEM) | Depuy Intl., Ltd. | Jun 5, 1995 | SESE |
| K951085 | PADGETT AIR DERMATOME, MODEL A | Padgett Instruments, Inc. | May 15, 1995 | SESE |
| K940208 | AESCULAP ACCU-DERMATOME | Aesculap, Inc. | Feb 24, 1994 | SESE |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | U. S. Diagnostics, Inc. | Oct 3, 1986 | SESE |
| K861285 | SKIN MESH DEVICE | Precision Modified Devices | Apr 17, 1986 | SESE |
| K861138 | MASH DERMATOME | Mecron Medical Products, Inc. | Apr 14, 1986 | SESE |
| K860925 | DERMASPANDERE | Mri Ventures, Inc. | Mar 28, 1986 | SESE |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | Downs Surgical , Ltd. | Aug 2, 1984 | SESE |
| K830993 | AMPLIGREFFE | Prothia USA, Inc. | May 3, 1983 | SESE |
| K792332 | DAVOL/SIMON DERMATOME | Davol, Inc. | Dec 6, 1979 | SESE |
Top Applicants
- U. S. Diagnostics, Inc. — 1 clearance
- Prothia USA, Inc. — 1 clearance
- Precision Modified Devices — 1 clearance
- Padgett Instruments, Inc. — 1 clearance
- Mri Ventures, Inc. — 1 clearance
