Rasp
A surgical rasp is a coarse-surfaced handheld instrument used in general and plastic surgery to roughen, shape, or smooth bone surfaces, typically during procedures involving facial or nasal bones. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating minimal risk and general controls only. Product code HTR falls under the General and Plastic Surgery medical specialty.
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Basic Information
- Product Code
- HTR
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870349 | BIODYNAMICS FEMORAL CANAL BRUSH #1201 | Feb 13, 1987 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K870333 | BIODYNAMICS SMALL JOINT BRUSH #1203 | Feb 13, 1987 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K870329 | ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 | Feb 13, 1987 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K813093 | RICHARDS ACETABULAR BRUSH | Nov 20, 1981 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
| K812506 | THE ARTHROFILE | Sep 24, 1981 | Substantially Equivalent | Dyonics, Inc. |
| K780771 | MICRO RASPS | May 16, 1978 | Substantially Equivalent | Amsco Co. |
| K771016 | INTERMEDULLARY BRUSH | Jan 12, 1978 | Substantially Equivalent | Howmedica Corp. |
| K771745 | RASPS FOR SCRAPING BONE | Sep 28, 1977 | Substantially Equivalent | Depuy, Inc. |
| K760109 | PROSTHESIS, TOTAL HIP-RASP | Jul 20, 1976 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 268 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 268 registration numbers. Click on an entry to view related FDA registrations.