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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 the device name listed in this FDA 510(k) record. The listed applicant is Curvebeam, LLC. It received FDA 510(k) clearance on 2024-07-12 under 510(k) 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. The listed applicant is Curvebeam, LLC. The 510(k) number is K241713.

When did HiRise (1040-230) receive FDA 510(k) clearance?

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

Who is the listed applicant for HiRise (1040-230)?

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

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

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

Other records listing Curvebeam, 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.

K203187HiRiseK181962CubeVueK180727LineUpK170789In Reach

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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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