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)

MADgic Laryngo-Tracheal Mucosal Atomization Device

K-Number: K153470 · 2016-08-19

ApplicantTeleflex Medical
Decision Date2016-08-19
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MADgic Laryngo-Tracheal Mucosal Atomization Device is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2016-08-19 under approval number K153470. The device is classified under product code CCT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADgic Laryngo-Tracheal Mucosal Atomization Device?

MADgic Laryngo-Tracheal Mucosal Atomization Device is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Teleflex Medical. The 510(k) number is K153470.

When was MADgic Laryngo-Tracheal Mucosal Atomization Device approved by the FDA?

MADgic Laryngo-Tracheal Mucosal Atomization Device received FDA 510(k) clearance on 2016-08-19, under approval number K153470.

What company makes MADgic Laryngo-Tracheal Mucosal Atomization Device?

MADgic Laryngo-Tracheal Mucosal Atomization Device is manufactured by Teleflex Medical.

What is the FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device?

The FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device is CCT.

Related Clinical Trials

NCT07601230 Polyp Pretreatment Device for SSL Diagnosis NOT_YET_RECRUITING NCT07600502 Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics. NOT_YET_RECRUITING NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING NCT05414448 Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection COMPLETED NCT06443970 Low and High Flow Suctioning in Intubated Infants RECRUITING NCT03737734 Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT) ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 39964125 Potential health benefits of lactoferrin and derived peptides - how to qualify as a medical device? Critical reviews in microbiology (2025)

Other Devices by Teleflex Medical

K161758Weck Auto Endo10 Automatic Endoscopic Clip Applier K180253Sheridan Endobronchial Tubes K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device K173596Rusch Intermittent Urethral Catheters K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

View all 20 devices →

Related Devices (Code: CCT)

K172956Medicant Mucosal AtomizerMedica Holdings, LLC K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor

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.

↑