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FDA 510(k)

Voyant Fine Fusion Device (EB230)

K-Number: K202818 · 2021-12-16

ApplicantApplied Medical
Decision Date2021-12-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant Fine Fusion Device (EB230) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K202818. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant Fine Fusion Device (EB230)?

Voyant Fine Fusion Device (EB230) is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Applied Medical. The 510(k) number is K202818.

When did Voyant Fine Fusion Device (EB230) receive FDA 510(k) clearance?

Voyant Fine Fusion Device (EB230) received FDA 510(k) clearance on 2021-12-16, under 510(k) number K202818.

Who is the listed applicant for Voyant Fine Fusion Device (EB230)?

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

What is the FDA product code for Voyant Fine Fusion Device (EB230)?

The FDA product code for Voyant Fine Fusion Device (EB230) is GEI.

Other records listing Applied Medical 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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