FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANUAL RONGEUR
K Number: K874954
·
Decision Dec 30, 1987
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
4
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- MANUAL RONGEUR
- K Number
- K874954
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Solway, Inc.
- Date Received
- December 2, 1987
- Decision Date
- December 30, 1987
- Product Code
- HTX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HTX | Rongeur | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTX), ordered by most recent decision date.
BACK RADIUS CUTTER
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ORTHOPEDIC FORCEPS
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SURGICAL INSTRUMENTS, ORTHOPEDIC
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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 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Dec 30, 1987 | Substantially Equivalent |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Dec 30, 1987 | Substantially Equivalent |