VisionAir Enhanced Stock Stent— 510(k) K261541

Name: FDA 510(k) clearance K261541
Creator: U.S. Food and Drug Administration
Published: 2026-06-01

Substantially Equivalent

VisionAir Solutions

FDA 510(k) clearance K261541 for VisionAir Enhanced Stock Stent, Substantially Equivalent on 2026-06-01. Applicant: VisionAir Solutions. Device class: 2.

Clearance details

Applicant: VisionAir Solutions
Product code: Code NWA
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2026-05-08
Decision date: 2026-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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K213969 — VisionAir Patient-Specific Airway Stent2022-10-07
K182743 — Patient-Specific Airway Stent2019-10-23
K971509 — ENDOXANE1997-08-21
K894380 — DUMON TRACHEOBRONCHIAL STENT1989-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.