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FDA 510(k)

SPiN Vision Video Bronchoscope System

K-Number: K202346 · 2021-02-19

ApplicantVeran Medical Technologies, Inc.
Decision Date2021-02-19
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPiN Vision Video Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202346. 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 SPiN Vision Video Bronchoscope System?

SPiN Vision Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K202346.

When did SPiN Vision Video Bronchoscope System receive FDA 510(k) clearance?

SPiN Vision Video Bronchoscope System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202346.

Who is the listed applicant for SPiN Vision Video Bronchoscope System?

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

What is the FDA product code for SPiN Vision Video Bronchoscope System?

The FDA product code for SPiN Vision Video Bronchoscope System is EOQ.

Other records listing Veran Medical Technologies, 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.

K170023SPiN Thoracic Navigation System

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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