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FDA 510(k)

Reprieve by RegenesisTM

K-Number: K223620 · 2023-05-24

ApplicantRegenesis Biomedical, Inc.
Decision Date2023-05-24
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Reprieve by RegenesisTM is a medical device manufactured by Regenesis Biomedical, Inc.. It received FDA 510(k) clearance on 2023-05-24 under approval number K223620. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprieve by RegenesisTM?

Reprieve by RegenesisTM is a medical device that received FDA 510(k) clearance on 2023-05-24. It is manufactured by Regenesis Biomedical, Inc.. The 510(k) number is K223620.

When was Reprieve by RegenesisTM approved by the FDA?

Reprieve by RegenesisTM received FDA 510(k) clearance on 2023-05-24, under approval number K223620.

What company makes Reprieve by RegenesisTM?

Reprieve by RegenesisTM is manufactured by Regenesis Biomedical, Inc..

What is the FDA product code for Reprieve by RegenesisTM?

The FDA product code for Reprieve by RegenesisTM is IMJ.

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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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