FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELF-RETAINING RETRACTOR FOR NEUROSURGERY
K Number: K874956
·
Decision Jan 28, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
42
Applicant Total
13
Review Days
57
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Basic Information
- Device Name
- SELF-RETAINING RETRACTOR FOR NEUROSURGERY
- K Number
- K874956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Solway, Inc.
- Date Received
- December 2, 1987
- Decision Date
- January 28, 1988
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
Similar 510(k) Clearances
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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 |
| 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 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Dec 30, 1987 | Substantially Equivalent |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Dec 30, 1987 | Substantially Equivalent |