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FDA 510(k)

Synergy

K-Number: K210954 · 2021-06-29

ApplicantYrs Group, Inc.
Decision Date2021-06-29
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Synergy is the device name listed in this FDA 510(k) record. The listed applicant is Yrs Group, Inc.. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K210954. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synergy?

Synergy is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Yrs Group, Inc.. The 510(k) number is K210954.

When did Synergy receive FDA 510(k) clearance?

Synergy received FDA 510(k) clearance on 2021-06-29, under 510(k) number K210954.

Who is the listed applicant for Synergy?

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

What is the FDA product code for Synergy?

The FDA product code for Synergy is OHS.

Other records listing Yrs Group, 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.

K220064Synergy Marble (Model: Opasm)

Related Devices (Code: OHS)

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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