Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SolidAIRity III Airway Stabilization System

K-Number: K190630 · 2019-10-09

ApplicantSecurisyn Medical, LLC
Decision Date2019-10-09
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SolidAIRity III Airway Stabilization System is a medical device manufactured by Securisyn Medical, LLC. It received FDA 510(k) clearance on 2019-10-09 under approval number K190630. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SolidAIRity III Airway Stabilization System?

SolidAIRity III Airway Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Securisyn Medical, LLC. The 510(k) number is K190630.

When was SolidAIRity III Airway Stabilization System approved by the FDA?

SolidAIRity III Airway Stabilization System received FDA 510(k) clearance on 2019-10-09, under approval number K190630.

What company makes SolidAIRity III Airway Stabilization System?

SolidAIRity III Airway Stabilization System is manufactured by Securisyn Medical, LLC.

What is the FDA product code for SolidAIRity III Airway Stabilization System?

The FDA product code for SolidAIRity III Airway Stabilization System is BTR.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT07574918 Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.

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.

↑