FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES
K Number: K874952
·
Decision Dec 30, 1987
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES
- K Number
- K874952
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Solway, Inc.
- Date Received
- December 2, 1987
- Decision Date
- December 30, 1987
- Product Code
- HBG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | FDA class 2 | Neurology |
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Other Clearances by Solway, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | Feb 5, 1988 | Substantially Equivalent |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | Feb 2, 1988 | Substantially Equivalent |
| K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY | Jan 28, 1988 | Substantially Equivalent |
| K874964 | DENTAL HAND INSTRUMENTS | Jan 27, 1988 | Substantially Equivalent |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | Jan 22, 1988 | Substantially Equivalent |
| K874966 | TUNING FORKS | Jan 4, 1988 | Substantially Equivalent |
| K874950 | MICROSURGICAL INSTRUMENTS | Dec 30, 1987 | Substantially Equivalent |
| K874959 | VASCULAR CLAMP | Dec 30, 1987 | Substantially Equivalent |
| K874954 | MANUAL RONGEUR | Dec 30, 1987 | Substantially Equivalent |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Dec 30, 1987 | Substantially Equivalent |