Product Code: HTF
FDA class 1
21 CFR 878.4800
Curette
General, Plastic Surgery
A curette is a handheld surgical instrument with a spoon-shaped or loop-shaped tip used to scrape, remove, or debride tissue, bone, or other material from a body cavity or surface. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk and general controls only. Product code HTF falls under the General and Plastic Surgery medical specialty.
510(k)s
3
FEI Numbers
324
Registration Numbers
324
Unique Applicants
3
Years Active
5
Basic Information
- Product Code
- HTF
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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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 |
|---|---|---|---|---|
| K890252 | BONE CURETTE | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K870778 | ACROMED WALLIE-HEINIG CURETTES | Mar 09, 1987 | Substantially Equivalent | BUCKMAN CO., INC. |
| K841979 | 4MM CUP CURRETTE | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
FEI Numbers
This FDA classification entry is associated with 324 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 324 registration numbers. Click on an entry to view related FDA registrations.