ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
FDA 510(k) clearance K072720 · decided 2008-04-11
Clearance details
- K-number
- K072720
- Device name
- ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
- Applicant
- Alveolus, Inc.
- Decision
- Unknown
- Date received
- 2007-09-25
- Decision date
- 2008-04-11
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, recall (Z-0801-2010) | Merit Medical Systems, Inc. | 2010-02-22 |
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, recall (Z-0802-2010) | Merit Medical Systems, Inc. | 2010-02-22 |
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, recall (Z-0803-2010) | Merit Medical Systems, Inc. | 2010-02-22 |
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, recall (Z-0804-2010) | Merit Medical Systems, Inc. | 2010-02-22 |
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, recall (Z-0805-2010) | Merit Medical Systems, Inc. | 2010-02-22 |
| Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, recall (Z-0806-2010) | Merit Medical Systems, Inc. | 2010-02-22 |