FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GI SUPPLY BILIARY STENT
K Number: K031360
·
Decision Sep 24, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
8
Review Days
147
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Basic Information
- Device Name
- GI SUPPLY BILIARY STENT
- K Number
- K031360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gi Supply
- Date Received
- April 30, 2003
- Decision Date
- September 24, 2003
- 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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| K970186 | GI SUPPLY PARACENTESIS PUMP | Feb 14, 1997 | Substantially Equivalent |
| K944903 | HP-FAST | Apr 20, 1995 | Substantially Equivalent |
| K931044 | OXY-BLOC | Oct 4, 1993 | Substantially Equivalent |
| K915816 | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY | Mar 27, 1992 | Substantially Equivalent |