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FDA 510(k)

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

K-Number: K220399 · 2022-06-16

ApplicantOTU Medical, Inc.
Decision Date2022-06-16
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is a medical device manufactured by OTU Medical, Inc.. It received FDA 510(k) clearance on 2022-06-16 under approval number K220399. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is a medical device that received FDA 510(k) clearance on 2022-06-16. It is manufactured by OTU Medical, Inc.. The 510(k) number is K220399.

When was WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System approved by the FDA?

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System received FDA 510(k) clearance on 2022-06-16, under approval number K220399.

What company makes WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is manufactured by OTU Medical, Inc..

What is the FDA product code for WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

The FDA product code for WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is EOQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by OTU Medical, Inc.

K181977WiScope Digital Endoscope System K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

Related Devices (Code: EOQ)

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc. K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc. K171492B7 2C Occlusion BalloonSpiration, Inc. K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation

Official Source

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