FDA 510(k)

VisionAir Enhanced Stock Stent

K-Number: K261541 · 2026-06-01

Decision Date2026-06-01

Product CodeNWA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VisionAir Enhanced Stock Stent is the device name listed in this FDA 510(k) record. The listed applicant is VisionAir Solutions. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K261541. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisionAir Enhanced Stock Stent?

VisionAir Enhanced Stock Stent is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is VisionAir Solutions. The 510(k) number is K261541.

When did VisionAir Enhanced Stock Stent receive FDA 510(k) clearance?

VisionAir Enhanced Stock Stent received FDA 510(k) clearance on 2026-06-01, under 510(k) number K261541.

Who is the listed applicant for VisionAir Enhanced Stock Stent?

The FDA 510(k) record lists VisionAir Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisionAir Enhanced Stock Stent?

The FDA product code for VisionAir Enhanced Stock Stent is NWA.

Related Devices (Code: NWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243126TRACHEOBRONXANE™ DUMON®Novatech SA K213969VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions K182743Patient-Specific Airway StentNew Cos, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.