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FDA 510(k)

Reach Needle

K-Number: K240253 · 2024-03-21

ApplicantAerin Medical, Inc.
Decision Date2024-03-21
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Reach Needle is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K240253. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reach Needle?

Reach Needle is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K240253.

When did Reach Needle receive FDA 510(k) clearance?

Reach Needle received FDA 510(k) clearance on 2024-03-21, under 510(k) number K240253.

Who is the listed applicant for Reach Needle?

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

What is the FDA product code for Reach Needle?

The FDA product code for Reach Needle is BSP.

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Other records listing Aerin Medical, Inc. as applicant

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Related Devices (Code: BSP)

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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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