FDA 510(k)

Voyant® Open Fusion Device (EB240/Open Fusion)

K-Nummer: K252740 · 2025-11-04

AntragstellerApplied Medical Resources Corp.

Entscheidungsdatum2025-11-04

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Voyant® Open Fusion Device (EB240/Open Fusion) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K252740. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Voyant® Open Fusion Device (EB240/Open Fusion)?

Voyant® Open Fusion Device (EB240/Open Fusion) is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K252740.

When did Voyant® Open Fusion Device (EB240/Open Fusion) receive FDA 510(k) clearance?

Voyant® Open Fusion Device (EB240/Open Fusion) received FDA 510(k) clearance on 2025-11-04, under 510(k) number K252740.

Who is the listed applicant for Voyant® Open Fusion Device (EB240/Open Fusion)?

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

What is the FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion)?

The FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion) is GEI.

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Offizielle Quelle

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