FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANDARD SCREW DRIVER
K Number: K872387
·
Decision Jul 16, 1987
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
2
Applicant Total
28
Review Days
27
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Basic Information
- Device Name
- STANDARD SCREW DRIVER
- K Number
- K872387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Med-Tool, Inc.
- Date Received
- June 19, 1987
- Decision Date
- July 16, 1987
- Product Code
- LRZ
- 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 |
|---|---|---|---|
| LRZ | Screwdriver, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRZ), ordered by most recent decision date.
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
1.1 SCREWDRIVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Med-Tool, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874357 | TAPERED PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874356 | PIN PUNCH | Nov 23, 1987 | Substantially Equivalent |
| K874359 | ADJUSTABLE WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K874358 | COMBINATION WRENCHES | Nov 23, 1987 | Substantially Equivalent |
| K872388 | NAIL SET | Jul 23, 1987 | Substantially Equivalent |
| K872385 | VICE OR BENCH VICE | Jul 16, 1987 | Substantially Equivalent |
| K872389 | PRECISION SCREW DRIVER SET | Jul 15, 1987 | Substantially Equivalent |
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Jul 2, 1987 | Substantially Equivalent |
| K872386 | C CLAMP | Jul 2, 1987 | Substantially Equivalent |
| K864018 | HACKSAW | Oct 30, 1986 | Substantially Equivalent |