FDA 510(k)

Gem Flow Now (GEM2770-FN)

K-Number: K233394 · 2024-01-28

ApplicantSynovis Micro Companies Alliance

Decision Date2024-01-28

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Gem Flow Now (GEM2770-FN) is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance. It received FDA 510(k) clearance on 2024-01-28 under 510(k) number K233394. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gem Flow Now (GEM2770-FN)?

Gem Flow Now (GEM2770-FN) is a medical device that received FDA 510(k) clearance on 2024-01-28. The listed applicant is Synovis Micro Companies Alliance. The 510(k) number is K233394.

When did Gem Flow Now (GEM2770-FN) receive FDA 510(k) clearance?

Gem Flow Now (GEM2770-FN) received FDA 510(k) clearance on 2024-01-28, under 510(k) number K233394.

Who is the listed applicant for Gem Flow Now (GEM2770-FN)?

The FDA 510(k) record lists Synovis Micro Companies Alliance as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gem Flow Now (GEM2770-FN)?

The FDA product code for Gem Flow Now (GEM2770-FN) is IYN.

Other records listing Synovis Micro Companies Alliance 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.

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Related Devices (Code: IYN)

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.