Mallet, Surgical, General & Plastic Surgery
The Mallet, Surgical, General and Plastic Surgery (product code GFJ) is a handheld striking instrument used in conjunction with osteotomes, chisels, or other manual instruments to deliver controlled force during bone work in 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 878.4800 in the General, Plastic Surgery specialty (SU), this device has no special regulatory flags.
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Basic Information
- Product Code
- GFJ
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K851789 | 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY | Jun 20, 1985 | Substantially Equivalent | Artiberia |
| K844017 | MICROTENS 7757 T.E.N.S. STIMULATOR | Nov 30, 1984 | Substantially Equivalent | Rabar, Inc. |
| K822204 | ENT MALLETS | Sep 17, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 173 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 173 registration numbers. Click on an entry to view related FDA registrations.