FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
R STENT BILIARY ENDOPROSTHESIS
K Number: K010107
·
Decision Jul 31, 2001
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
8
Review Days
200
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Basic Information
- Device Name
- R STENT BILIARY ENDOPROSTHESIS
- K Number
- K010107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Orbus Medical Technologies
- Date Received
- January 12, 2001
- Decision Date
- July 31, 2001
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Orbus Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K041370 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | Jun 24, 2004 | Unknown |
| K041032 | MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | May 10, 2004 | Unknown |
| K040550 | LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | Mar 16, 2004 | Unknown |
| K033212 | LIFESTENT SDS BILIARY ENDOPROSTHESIS | Oct 30, 2003 | Unknown |
| K023308 | LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS | Apr 14, 2003 | Unknown |
| K023121 | LIFESTENT BILIARY ENDOPROSTHESIS | Mar 10, 2003 | Unknown |
| K023248 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | Feb 11, 2003 | Unknown |