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FDA 510(k)

Heager Medical Laser Family (Sabrina/Adolf)

Número K: K250261 · 2025-08-26

RequerenteHeager GmbH
Data da decisão2025-08-26
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Heager Medical Laser Family (Sabrina/Adolf) is the device name listed in this FDA 510(k) record. The listed applicant is Heager GmbH. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K250261. 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 Heager Medical Laser Family (Sabrina/Adolf)?

Heager Medical Laser Family (Sabrina/Adolf) is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Heager GmbH. The 510(k) number is K250261.

When did Heager Medical Laser Family (Sabrina/Adolf) receive FDA 510(k) clearance?

Heager Medical Laser Family (Sabrina/Adolf) received FDA 510(k) clearance on 2025-08-26, under 510(k) number K250261.

Who is the listed applicant for Heager Medical Laser Family (Sabrina/Adolf)?

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

What is the FDA product code for Heager Medical Laser Family (Sabrina/Adolf)?

The FDA product code for Heager Medical Laser Family (Sabrina/Adolf) is GEX. This falls under the Gastroenterology category.

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