FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCALPEL HANDLE
K Number: K854858
·
Decision Dec 24, 1985
Classifications
1
FEI Numbers
430
Registration Numbers
430
Same Product Code
15
Applicant Total
15
Review Days
19
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Basic Information
- Device Name
- SCALPEL HANDLE
- K Number
- K854858
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medelec Intl. Corp.
- Date Received
- December 5, 1985
- Decision Date
- December 24, 1985
- Product Code
- GDZ
- 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 |
|---|---|---|---|
| GDZ | Handle, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Medelec Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961013 | DISPOSABLE NEEDLE ELECTRODE | Dec 20, 1996 | Substantially Equivalent |
| K935017 | TD50 ELECTROMYOGRAPH | Jul 28, 1994 | Substantially Equivalent |
| K922548 | MEDELEC 2110 AND 2114 EEG | Nov 3, 1992 | Substantially Equivalent |
| K920127 | ELECTROENCEPHALOGRAPH RECORDING SYSTEM | Jun 10, 1992 | Substantially Equivalent |
| K912775 | SAPPHIRE 4ME EMG/EP SYSTEM | Nov 8, 1991 | Substantially Equivalent |
| K865106 | PROPHYLACTIC (CONDOM) MR. JOHNNY | May 20, 1987 | Substantially Equivalent |
| K863491 | BLOOD SPECIMEN COLLECTION DEVICES | Oct 24, 1986 | Substantially Equivalent |
| K854622 | PROPHYLACTIC (CONDOM) | Apr 11, 1986 | Substantially Equivalent |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | Jan 9, 1986 | Substantially Equivalent |
| K854860 | BLADES, SCALPEL CARBON STEET | Dec 24, 1985 | Substantially Equivalent |