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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 a medical device manufactured by Contra Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2025-04-30 under approval 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. It is manufactured by Contra Healthcare Solutions, LLC. The 510(k) number is K243541.

When was LumiRex Bronchoscope approved by the FDA?

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

What company makes LumiRex Bronchoscope?

LumiRex Bronchoscope is manufactured by Contra Healthcare Solutions, LLC.

What is the FDA product code for LumiRex Bronchoscope?

The FDA product code for LumiRex Bronchoscope is EOQ.

Other Devices by Contra Healthcare Solutions, LLC

K243532LumiRex Ureteroscope

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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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