Dermatome
A Dermatome (product code GFD) is a surgical instrument used to cut thin, uniform slices of skin, typically for harvesting split-thickness skin grafts used in wound coverage and reconstructive plastic surgery. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device carries no special flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GFD
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K965256 | DMS-1000C DERMOABRADER | Dec 09, 1996 | Substantially Equivalent | Mattioli Engineering, Srl |
| K962371 | DERMTOME BLADE | Aug 29, 1996 | Substantially Equivalent | Dsp Worldwide |
| K945594 | DECA DERMATOME (MICROMOTOR SYSTEM) | Jun 05, 1995 | Substantially Equivalent | Depuy Intl., Ltd. |
| K951085 | PADGETT AIR DERMATOME, MODEL A | May 15, 1995 | Substantially Equivalent | Padgett Instruments, Inc. |
| K940208 | AESCULAP ACCU-DERMATOME | Feb 24, 1994 | Substantially Equivalent | Aesculap, Inc. |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | Oct 03, 1986 | Substantially Equivalent | U. S. Diagnostics, Inc. |
| K861285 | SKIN MESH DEVICE | Apr 17, 1986 | Substantially Equivalent | Precision Modified Devices |
| K861138 | MASH DERMATOME | Apr 14, 1986 | Substantially Equivalent | Mecron Medical Products, Inc. |
| K860925 | DERMASPANDERE | Mar 28, 1986 | Substantially Equivalent | Mri Ventures, Inc. |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | Aug 02, 1984 | Substantially Equivalent | Downs Surgical , Ltd. |
| K830993 | AMPLIGREFFE | May 03, 1983 | Substantially Equivalent | Prothia USA, Inc. |
| K792332 | DAVOL/SIMON DERMATOME | Dec 06, 1979 | Substantially Equivalent | Davol, Inc. |
FEI Numbers
This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.