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FDA 510(k)

Synexis Sphere Rx

K-Number: K221540 · 2023-06-14

ApplicantSynexis, LLC
Decision Date2023-06-14
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synexis Sphere Rx is a medical device manufactured by Synexis, LLC. It received FDA 510(k) clearance on 2023-06-14 under approval 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. It is manufactured by Synexis, LLC. The 510(k) number is K221540.

When was Synexis Sphere Rx approved by the FDA?

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

What company makes Synexis Sphere Rx?

Synexis Sphere Rx is manufactured by Synexis, LLC.

What is the FDA product code for Synexis Sphere Rx?

The FDA product code for Synexis Sphere Rx is FRA.

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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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