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FDA 510(k)

LumiRex Bronchoscope

K-Number: K243541 · 2025-04-30

ApplicantContra Healthcare Solutions, LLC
Decision Date2025-04-30
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LumiRex Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Contra Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K243541. 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 LumiRex Bronchoscope?

LumiRex Bronchoscope is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is Contra Healthcare Solutions, LLC. The 510(k) number is K243541.

When did LumiRex Bronchoscope receive FDA 510(k) clearance?

LumiRex Bronchoscope received FDA 510(k) clearance on 2025-04-30, under 510(k) number K243541.

Who is the listed applicant for LumiRex Bronchoscope?

The FDA 510(k) record lists Contra Healthcare Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumiRex Bronchoscope?

The FDA product code for LumiRex Bronchoscope is EOQ.

Other records listing Contra Healthcare Solutions, LLC 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.

K243532LumiRex Ureteroscope

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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