FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOUBLE-EDGE CURETTE
K Number: K800733
·
Decision Apr 8, 1980
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
4
Applicant Total
19
Review Days
7
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Basic Information
- Device Name
- DOUBLE-EDGE CURETTE
- K Number
- K800733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stainless Mfg., Inc.
- Date Received
- April 1, 1980
- Decision Date
- April 8, 1980
- Product Code
- HXP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HXP | Instrument, Bending Or Contouring | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXP), ordered by most recent decision date.
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Other Clearances by Stainless Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841980 | SIDE CUTTING SERRATED BLADE | Aug 15, 1984 | Substantially Equivalent |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Jun 19, 1984 | Substantially Equivalent |
| K841976 | HOOK KNIFE 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent |
| K841981 | 4MM & 5MM FILE | Jun 19, 1984 | Substantially Equivalent |
| K841973 | BANANA KNIFE SERRATED | Jun 19, 1984 | Substantially Equivalent |
| K841982 | MENISCOTOME 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent |
| K841975 | ROSETTE KNIFE 4MM | Jun 19, 1984 | Substantially Equivalent |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Jun 19, 1984 | Substantially Equivalent |
| K841970 | CAMELBACK HANDLE-K841969-LABELING | Jun 19, 1984 | Substantially Equivalent |
| K841972 | BANANA KNIFE - K841969-LABELING | Jun 19, 1984 | Substantially Equivalent |