FDA product code GFD: Dermatome
GFD is the FDA product code for dermatome. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 12 510(k) submissions under GFD, from 12 different applicants. The average 510(k) review took 58 days (median 38). FDA has posted 22 recalls for GFD devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dermatome |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GFD clearance
Top GFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mattioli Engineering, Srl | 1 | 1996-12-09 |
| Dsp Worldwide | 1 | 1996-08-29 |
| Depuy Intl., Ltd. | 1 | 1995-06-05 |
| Padgett Instruments, Inc. | 1 | 1995-05-15 |
| Aesculap, Inc. | 1 | 1994-02-24 |
7 more applicants have GFD clearances. See the full list in Caduvo.
Most recent GFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965256 | Mattioli Engineering, Srl | DMS-1000C DERMOABRADER | 1996-12-09 | 115 |
| K962371 | Dsp Worldwide | DERMTOME BLADE | 1996-08-29 | 71 |
| K945594 | Depuy Intl., Ltd. | DECA DERMATOME (MICROMOTOR SYSTEM) | 1995-06-05 | 203 |
| K951085 | Padgett Instruments, Inc. | PADGETT AIR DERMATOME, MODEL A | 1995-05-15 | 67 |
| K940208 | Aesculap, Inc. | AESCULAP ACCU-DERMATOME | 1994-02-24 | 41 |
Recalls for GFD devices
22 product recalls in 11 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-24.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 3 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code GFD?
GFD is the FDA product code for dermatome. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GFD?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFD?
Across 12 cleared submissions the average was 58 days from receipt to decision (median 38).
Which companies have the most GFD clearances?
Mattioli Engineering, Srl (1); Dsp Worldwide (1); Depuy Intl., Ltd. (1); Padgett Instruments, Inc. (1); Aesculap, Inc. (1).
Have GFD devices been recalled?
Yes: 22 product recalls across 11 recall events; the most recent began 2025-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GFD
- Run a recall and safety report across every GFD manufacturer
- Watch product code GFD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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