FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
K Number: K081956
·
Decision Jan 9, 2009
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
6
Review Days
184
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Basic Information
- Device Name
- MEDINOL X-SUIT NIR BILIARY METALLIC STENT
- K Number
- K081956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medinol, Ltd.
- Date Received
- July 9, 2008
- Decision Date
- January 9, 2009
- 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 Medinol, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173581 | Gallant PTCA Dilatation Catheter | Jan 25, 2018 | Substantially Equivalent |
| K162434 | NC Gallant PTCA Catheter | Jan 19, 2017 | Substantially Equivalent |
| K150487 | X-Suit NIR Biliary Metallic Stent | Feb 12, 2016 | Unknown |
| K002130 | NIR BILIARY STENT | Oct 30, 2000 | Unknown |
| K973171 | NIR BILIARY STENT | Nov 13, 1998 | Substantially Equivalent |