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FDA 510(k)

Synchrony (20-3000)

K-Number: K242704 · 2025-06-05

ApplicantSynapse Biomedical, Inc.
Decision Date2025-06-05
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Synchrony (20-3000) is a medical device manufactured by Synapse Biomedical, Inc.. It received FDA 510(k) clearance on 2025-06-05 under approval number K242704. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synchrony (20-3000)?

Synchrony (20-3000) is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Synapse Biomedical, Inc.. The 510(k) number is K242704.

When was Synchrony (20-3000) approved by the FDA?

Synchrony (20-3000) received FDA 510(k) clearance on 2025-06-05, under approval number K242704.

What company makes Synchrony (20-3000)?

Synchrony (20-3000) is manufactured by Synapse Biomedical, Inc..

What is the FDA product code for Synchrony (20-3000)?

The FDA product code for Synchrony (20-3000) is GZI.

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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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