FDA 510(k)

MANTA Laser

Número K: K222701 · 2022-11-18

Data da decisão2022-11-18

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MANTA Laser is the device name listed in this FDA 510(k) record. The listed applicant is Squalus Med , Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222701. 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 MANTA Laser?

MANTA Laser is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Squalus Med , Ltd.. The 510(k) number is K222701.

When did MANTA Laser receive FDA 510(k) clearance?

MANTA Laser received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222701.

Who is the listed applicant for MANTA Laser?

The FDA 510(k) record lists Squalus Med , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANTA Laser?

The FDA product code for MANTA Laser is GEX. This falls under the Gastroenterology category.

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