FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
K Number: K072720
·
Decision Apr 11, 2008
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
12
Review Days
199
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
- K Number
- K072720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Alveolus, Inc.
- Date Received
- September 25, 2007
- Decision Date
- April 11, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.
Dilation Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoflux Biliary & Pancreatic Stent Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARE Wireguided Balloon Dilation Catheter (1235)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single use stone retrieval balloons
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Alveolus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Mar 11, 2009 | Unknown |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Nov 20, 2008 | Unknown |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Apr 24, 2008 | Substantially Equivalent |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Sep 19, 2007 | Unknown |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Jan 31, 2007 | Unknown |
| K060239 | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM | Mar 22, 2006 | Substantially Equivalent |
| K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Jul 11, 2005 | Substantially Equivalent |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | May 12, 2004 | Substantially Equivalent |
| K033053 | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Feb 25, 2004 | Substantially Equivalent |
| K032744 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Nov 13, 2003 | Substantially Equivalent |