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510(k) K072720

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM by Alveolus, Inc. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
April 11, 2008
Date Received
September 25, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Alveolus, Inc.

  • K083625 — AERO DV TRACHEOBRONCHIAL STENT SYSTEM (March 11, 2009)
  • K082284 — AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM (November 20, 2008)
  • K080838 — ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (April 24, 2008)
  • K071604 — ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM (September 19, 2007)
  • K062511 — AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX (January 31, 2007)
  • K060239 — ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM (March 22, 2006)
  • K051621 — ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (July 11, 2005)
  • K033990 — ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM (May 12, 2004)
  • K033053 — ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM (February 25, 2004)
  • K032744 — ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (November 13, 2003)

Other clearances for product code FGE

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  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)