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 a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2024-03-21 under approval 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. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K240253.
When was Reach Needle approved by the FDA?
Reach Needle received FDA 510(k) clearance on 2024-03-21, under approval number K240253.
What company makes Reach Needle?
Reach Needle is manufactured by Aerin Medical, Inc..
What is the FDA product code for Reach Needle?
The FDA product code for Reach Needle is 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.