FDA 510(k)

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)

K-Number: K152466 · 2016-05-19

Decision Date2016-05-19

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is a medical device manufactured by Prosurg, Inc.. It received FDA 510(k) clearance on 2016-05-19 under approval number K152466. 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 Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Prosurg, Inc.. The 510(k) number is K152466.

When was Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) approved by the FDA?

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) received FDA 510(k) clearance on 2016-05-19, under approval number K152466.

What company makes Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is manufactured by Prosurg, Inc..

What is the FDA product code for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

The FDA product code for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is EOQ.

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Other Devices by Prosurg, Inc.

K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

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. 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 K162611PeriFLEXSpiration, Inc.

Official Source

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