FDA 510(k)

OmniGuide RFID Surgical Laser Fibers

Número K: K230819 · 2023-04-21

Data da decisão2023-04-21

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

OmniGuide RFID Surgical Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Guide Holdings, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K230819. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OmniGuide RFID Surgical Laser Fibers?

OmniGuide RFID Surgical Laser Fibers is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Omni-Guide Holdings, Inc.. The 510(k) number is K230819.

When did OmniGuide RFID Surgical Laser Fibers receive FDA 510(k) clearance?

OmniGuide RFID Surgical Laser Fibers received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230819.

Who is the listed applicant for OmniGuide RFID Surgical Laser Fibers?

The FDA 510(k) record lists Omni-Guide Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniGuide RFID Surgical Laser Fibers?

The FDA product code for OmniGuide RFID Surgical Laser Fibers is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Omni-Guide Holdings, Inc. como candidato(a)

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Fonte oficial

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