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FDA 510(k)

VisionAir Patient-Specific Airway Stent

K-Number: K213969 · 2022-10-07

ApplicantNew Cos Inc. Dba Visionair Solutions
Decision Date2022-10-07
Product CodeNWA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VisionAir Patient-Specific Airway Stent is a medical device manufactured by New Cos Inc. Dba Visionair Solutions. It received FDA 510(k) clearance on 2022-10-07 under approval number K213969. 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 Patient-Specific Airway Stent?

VisionAir Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by New Cos Inc. Dba Visionair Solutions. The 510(k) number is K213969.

When was VisionAir Patient-Specific Airway Stent approved by the FDA?

VisionAir Patient-Specific Airway Stent received FDA 510(k) clearance on 2022-10-07, under approval number K213969.

What company makes VisionAir Patient-Specific Airway Stent?

VisionAir Patient-Specific Airway Stent is manufactured by New Cos Inc. Dba Visionair Solutions.

What is the FDA product code for VisionAir Patient-Specific Airway Stent?

The FDA product code for VisionAir Patient-Specific Airway Stent is NWA.

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

Related Devices (Code: NWA)

K182743Patient-Specific Airway StentNew Cos, Inc. K243126TRACHEOBRONXANE™ DUMON®Novatech SA

Official Source

View on FDA Database →

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

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