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FDA 510(k)

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

K-Number: K152466 · 2016-05-19

ApplicantProsurg, Inc.
Decision Date2016-05-19
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) 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. The listed applicant is Prosurg, Inc.. The 510(k) number is K152466.

When did Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) receive FDA 510(k) clearance?

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

Who is the listed applicant for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

The FDA 510(k) record lists Prosurg, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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.

NCT07726784Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural EffusionNOT_YET_RECRUITINGNCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITINGNCT07687628Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal FistulaRECRUITING

Other records listing Prosurg, Inc. as applicant

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.

K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaK152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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