FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BANANA KNIFE - K841969-LABELING
K Number: K841972
·
Decision Jun 19, 1984
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
20
Applicant Total
19
Review Days
36
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Basic Information
- Device Name
- BANANA KNIFE - K841969-LABELING
- K Number
- K841972
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Stainless Mfg., Inc.
- Date Received
- May 14, 1984
- Decision Date
- June 19, 1984
- Product Code
- HTZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HTZ | Instrument, Cutting, Orthopedic | FDA class 1 | General, Plastic Surgery |
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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 |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent |