Rasp, Surgical, General & Plastic Surgery
The Rasp, Surgical, General and Plastic Surgery (product code GAC) is a surgical instrument with an abrasive surface used to smooth, shape, or contour bone during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and not requiring a premarket notification submission. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GAC
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 180 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 180 registration numbers. Click on an entry to view related FDA registrations.