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FDA 510(k)

BonVie+

K-Number: K250346 · 2025-02-26

ApplicantElute, Inc.
Decision Date2025-02-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonVie+ is the device name listed in this FDA 510(k) record. The listed applicant is Elute, Inc.. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K250346. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BonVie+?

BonVie+ is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Elute, Inc.. The 510(k) number is K250346.

When did BonVie+ receive FDA 510(k) clearance?

BonVie+ received FDA 510(k) clearance on 2025-02-26, under 510(k) number K250346.

Who is the listed applicant for BonVie+?

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

What is the FDA product code for BonVie+?

The FDA product code for BonVie+ is MQV.

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Other records listing Elute, Inc. as applicant

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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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