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510(k) K080838

ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM by Alveolus, Inc. — Product Code ESW

K080838 is an FDA 510(k) premarket notification submitted by Alveolus, Inc. for the device "ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 24, 2008. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Alveolus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2008
Date Received
March 25, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
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)
  • K072720 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (April 11, 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 ESW

  • K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent Syst (July 10, 2026)
  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K240522 — Esophageal TTS Stent (March 22, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)

FDA data resources