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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 the device name listed in this FDA 510(k) record. The listed applicant is Synapse Biomedical, Inc.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) 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. The listed applicant is Synapse Biomedical, Inc.. The 510(k) number is K242704.

When did Synchrony (20-3000) receive FDA 510(k) clearance?

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

Who is the listed applicant for Synchrony (20-3000)?

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

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

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

Other records listing Synapse Biomedical, 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.

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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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