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

FDA 510(k)

IRRIS (Infra-Red-Red Intubation System)

K-Number: K171411 · 2018-01-12

ApplicantA.R Guide IN Medical , Ltd.
Decision Date2018-01-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IRRIS (Infra-Red-Red Intubation System) is the device name listed in this FDA 510(k) record. The listed applicant is A.R Guide IN Medical , Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171411. 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 IRRIS (Infra-Red-Red Intubation System)?

IRRIS (Infra-Red-Red Intubation System) is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is A.R Guide IN Medical , Ltd.. The 510(k) number is K171411.

When did IRRIS (Infra-Red-Red Intubation System) receive FDA 510(k) clearance?

IRRIS (Infra-Red-Red Intubation System) received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171411.

Who is the listed applicant for IRRIS (Infra-Red-Red Intubation System)?

The FDA 510(k) record lists A.R Guide IN Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIS (Infra-Red-Red Intubation System)?

The FDA product code for IRRIS (Infra-Red-Red Intubation System) is BTR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: BTR)

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.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

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.

↑