Product code GFD
- Device name
- Dermatome
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965256 | DMS-1000C DERMOABRADER | Mattioli Engineering, Srl | 1996-12-09 |
| K962371 | DERMTOME BLADE | Dsp Worldwide | 1996-08-29 |
| K945594 | DECA DERMATOME (MICROMOTOR SYSTEM) | Depuy Intl., Ltd. | 1995-06-05 |
| K951085 | PADGETT AIR DERMATOME, MODEL A | Padgett Instruments, Inc. | 1995-05-15 |
| K940208 | AESCULAP ACCU-DERMATOME | Aesculap, Inc. | 1994-02-24 |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | U. S. Diagnostics, Inc. | 1986-10-03 |
| K861285 | SKIN MESH DEVICE | Precision Modified Devices | 1986-04-17 |
| K861138 | MASH DERMATOME | Mecron Medical Products, Inc. | 1986-04-14 |
| K860925 | DERMASPANDERE | Mri Ventures, Inc. | 1986-03-28 |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | Downs Surgical , Ltd. | 1984-08-02 |
| K830993 | AMPLIGREFFE | Prothia USA, Inc. | 1983-05-03 |
| K792332 | DAVOL/SIMON DERMATOME | Davol, Inc. | 1979-12-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08717903490563 | Humeca D100 Dermatome blade | Humeca B.V. | 2025-08-19 |
| 08717903490020 | Micrograft gauze + cork plate, 1:3, 5-pack | Humeca B.V. | 2025-05-20 |
| 08717903490396 | MEEK set machine driven complete | Humeca B.V. | 2025-05-20 |
| 08717903490389 | MEEK set hand driven complete | Humeca B.V. | 2025-05-20 |
| 08717903490365 | D80 dermatome set | Humeca B.V. | 2025-05-20 |
| 08717903490358 | D42 dermatome set | Humeca B.V. | 2025-05-20 |
| 08717903490204 | Humeca blade for Zimmer® 8801-8821 dermatome | Humeca B.V. | 2025-05-20 |
| 08717903490198 | Humeca blade for Aesculap®/Acculan® dermatome | Humeca B.V. | 2025-05-20 |
| 08717903490174 | Humeca D42 Dermatome blade | Humeca B.V. | 2025-05-20 |
| 08717903490181 | Humeca blade for Padgett® model B, C and S dermatome | Humeca B.V. | 2025-05-20 |
| 08717903490013 | Micrograft gauze + cork plate, 1:3 | Humeca B.V. | 2025-05-19 |
| 08717903490075 | Micrograft gauze + cork plate, 1:9 | Humeca B.V. | 2025-05-19 |
| 08717903490068 | Micrograft gauze + cork plate, 1:6, 5-pack | Humeca B.V. | 2025-05-19 |
| 08717903490051 | Micrograft gauze + cork plate, 1:6 | Humeca B.V. | 2025-05-19 |
| 08717903490044 | Micrograft gauze + cork plate, 1:4, 5-pack | Humeca B.V. | 2025-05-19 |
| 08717903490037 | Micrograft gauze + cork plate, 1:4 | Humeca B.V. | 2025-05-19 |
| 08717903490006 | Micrograft gauze + cork plate, 1:2 | Humeca B.V. | 2025-05-19 |
| 08717903490082 | Humeca D80 Dermatome blade | Humeca B.V. | 2025-05-19 |
| 10381780277484 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277477 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277460 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277453 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277446 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277439 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277422 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277408 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277392 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277385 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277378 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
| 10381780277361 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |