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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 the device name listed in this FDA 510(k) record. The listed applicant is Regenesis Biomedical, Inc.. It received FDA 510(k) clearance on 2023-05-24 under 510(k) 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. The listed applicant is Regenesis Biomedical, Inc.. The 510(k) number is K223620.

When did Reprieve by RegenesisTM receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprieve by RegenesisTM?

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

What is the FDA product code for Reprieve by RegenesisTM?

The FDA product code for Reprieve by RegenesisTM is IMJ.

Related Devices (Code: IMJ)

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.

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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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