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FDA 510(k)

LumiRex Ureteroscope

K-Number: K243532 · 2025-04-28

ApplicantContra Healthcare Solutions, LLC
Decision Date2025-04-28
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LumiRex Ureteroscope is a medical device manufactured by Contra Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2025-04-28 under approval number K243532. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiRex Ureteroscope?

LumiRex Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Contra Healthcare Solutions, LLC. The 510(k) number is K243532.

When was LumiRex Ureteroscope approved by the FDA?

LumiRex Ureteroscope received FDA 510(k) clearance on 2025-04-28, under approval number K243532.

What company makes LumiRex Ureteroscope?

LumiRex Ureteroscope is manufactured by Contra Healthcare Solutions, LLC.

What is the FDA product code for LumiRex Ureteroscope?

The FDA product code for LumiRex Ureteroscope is FGB.

Other Devices by Contra Healthcare Solutions, LLC

K243541LumiRex Bronchoscope

Related Devices (Code: FGB)

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Official Source

View on FDA Database →

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

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