File, Surgical, General & Plastic Surgery
The Surgical File for General and Plastic Surgery (product code GEO) is a manual abrasive instrument used intraoperatively to smooth or contour bone surfaces during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls with no premarket notification requirement. Regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU), this instrument has no special flags for implantation, life support, GMP exemption, or third-party review eligibility.
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Basic Information
- Product Code
- GEO
- 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 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.