Product code GFD— General, Plastic Surgery
ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- Classification name
- Dermatome
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code GFD
FDA has cleared devices under product code GFD between 1979 and 1996, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1995
- 1994
- 1986
- 1984
- 1983
- 1979
Top applicants under product code GFD
Adverse events under product code GFD
product code GFD- Injury
- 544
- Malfunction
- 3,575
- Other
- 1
- Total
- 4,120
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GFD
- K965256 — DMS-1000C DERMOABRADER
- K962371 — DERMTOME BLADE
- K945594 — DECA DERMATOME (MICROMOTOR SYSTEM)
- K951085 — PADGETT AIR DERMATOME, MODEL A
- K940208 — AESCULAP ACCU-DERMATOME
- K862669 — ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K861285 — SKIN MESH DEVICE
- K861138 — MASH DERMATOME
- K860925 — DERMASPANDERE
- K842702 — ROSENBERG SKIN GRAFTING KNIVES
- K830993 — AMPLIGREFFE
- K792332 — DAVOL/SIMON DERMATOME
Data sourced from openFDA. This site is unofficial and independent of the FDA.