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FDA 510(k)

ReFlow System Mini

K-Number: K221918 · 2022-09-29

ApplicantAnuncia Medical, Inc.
Decision Date2022-09-29
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ReFlow System Mini is the device name listed in this FDA 510(k) record. The listed applicant is Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K221918. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReFlow System Mini?

ReFlow System Mini is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Anuncia Medical, Inc.. The 510(k) number is K221918.

When did ReFlow System Mini receive FDA 510(k) clearance?

ReFlow System Mini received FDA 510(k) clearance on 2022-09-29, under 510(k) number K221918.

Who is the listed applicant for ReFlow System Mini?

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

What is the FDA product code for ReFlow System Mini?

The FDA product code for ReFlow System Mini is JXG.

Other records listing Anuncia Medical, Inc. as applicant

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.

K223603Reflow System Mini and ReFlow Mini Flusher

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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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