FDA 510(k)

FLASH EVD System (10-0002)

Número K: K242480 · 2024-12-27

Data da decisão2024-12-27

Código do produtoHAW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLASH EVD System (10-0002) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical ULC. It received FDA 510(k) clearance on 2024-12-27 under 510(k) number K242480. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLASH EVD System (10-0002)?

FLASH EVD System (10-0002) is a medical device that received FDA 510(k) clearance on 2024-12-27. The listed applicant is 7D Surgical ULC. The 510(k) number is K242480.

When did FLASH EVD System (10-0002) receive FDA 510(k) clearance?

FLASH EVD System (10-0002) received FDA 510(k) clearance on 2024-12-27, under 510(k) number K242480.

Who is the listed applicant for FLASH EVD System (10-0002)?

The FDA 510(k) record lists 7D Surgical ULC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLASH EVD System (10-0002)?

The FDA product code for FLASH EVD System (10-0002) is HAW.

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