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FDA 510(k)

HiRise (1040-230)

K-Number: K241713 · 2024-07-12

ApplicantCurvebeam, LLC
Decision Date2024-07-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HiRise (1040-230) is a medical device manufactured by Curvebeam, LLC. It received FDA 510(k) clearance on 2024-07-12 under approval number K241713. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HiRise (1040-230)?

HiRise (1040-230) is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Curvebeam, LLC. The 510(k) number is K241713.

When was HiRise (1040-230) approved by the FDA?

HiRise (1040-230) received FDA 510(k) clearance on 2024-07-12, under approval number K241713.

What company makes HiRise (1040-230)?

HiRise (1040-230) is manufactured by Curvebeam, LLC.

What is the FDA product code for HiRise (1040-230)?

The FDA product code for HiRise (1040-230) is JAK.

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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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