FDA 510(k)

Synexis Sphere Rx

K-Number: K221540 · 2023-06-14

Decision Date2023-06-14

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Synexis Sphere Rx is the device name listed in this FDA 510(k) record. The listed applicant is Synexis, LLC. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K221540. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synexis Sphere Rx?

Synexis Sphere Rx is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Synexis, LLC. The 510(k) number is K221540.

When did Synexis Sphere Rx receive FDA 510(k) clearance?

Synexis Sphere Rx received FDA 510(k) clearance on 2023-06-14, under 510(k) number K221540.

Who is the listed applicant for Synexis Sphere Rx?

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

What is the FDA product code for Synexis Sphere Rx?

The FDA product code for Synexis Sphere Rx is FRA.

Related Devices (Code: FRA)

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.