FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIZA-RIBE NEEDLE (MODIFICATION)
K Number: K954882
·
Decision Nov 16, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
9
Review Days
98
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Basic Information
- Device Name
- RIZA-RIBE NEEDLE (MODIFICATION)
- K Number
- K954882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R-Med, Inc.
- Date Received
- August 10, 1995
- Decision Date
- November 16, 1995
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by R-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | Jul 17, 2000 | Substantially Equivalent |
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | Jan 11, 1996 | Substantially Equivalent |
| K953441 | RIZA-RIBE NEEDLE | Aug 18, 1995 | Substantially Equivalent |
| K950108 | R-MED MINI-RETRACTOR | May 11, 1995 | Substantially Equivalent |
| K942411 | R-MED DISPOSABLE PLUG | Mar 31, 1995 | Substantially Equivalent |
| K945637 | R-MED MOTORIZED LAPAROSCOPIC HANDLE | Dec 7, 1994 | Substantially Equivalent |
| K943818 | MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS | Aug 29, 1994 | Substantially Equivalent |
| K935031 | RIZA-RIBE NEEDLE | Apr 25, 1994 | Substantially Equivalent |