FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIZA BAND STRETCHER (RBS)-60000
K Number: K001236
·
Decision Jul 17, 2000
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
21
Applicant Total
9
Review Days
90
Basic Information
- Device Name
- RIZA BAND STRETCHER (RBS)-60000
- K Number
- K001236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R-MED, INC.
- Date Received
- April 18, 2000
- Decision Date
- July 17, 2000
- Product Code
- FHN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by R-MED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | Jan 11, 1996 | Substantially Equivalent |
| K954882 | RIZA-RIBE NEEDLE (MODIFICATION) | Nov 16, 1995 | 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 |