Bit, Surgical
The Bit, Surgical (product code GFG) is a removable cutting attachment used with powered surgical instrument systems for drilling or boring into bone or tissue during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk tier, subject to general controls with no premarket notification required. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GFG
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935225 | MITEK MODULAR DRILL BIT | Apr 07, 1994 | Substantially Equivalent | Mitek Surgical Products, Inc. |
| K821486 | MICRO DRILLS | Jun 09, 1982 | Substantially Equivalent | Spire Medical, Inc. |
| K821127 | KEY DRILL | Jun 03, 1982 | Substantially Equivalent | Key Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 102 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 102 registration numbers. Click on an entry to view related FDA registrations.