Chisel, Mastoid
Chisel, Mastoid is a surgical hand instrument used during mastoidectomy procedures to remove bone from the mastoid process of the temporal bone, as part of surgical treatment for chronic ear disease, cholesteatoma, or mastoiditis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYD, regulated under 21 CFR 878.4800, and falls within the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- JYD
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934367 | PC-MINI | Nov 08, 1993 | Substantially Equivalent | GE Medical Systems |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.