FDA 510(k)

Sistema Cirúrgico 7D - Aplicação Percutânea (7D Flash Frame)

Número K: K220522 · 2022-05-20

Data da decisão2022-05-20

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

7D Surgical System - Percutaneous Application (7D Flash Frame) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220522. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 7D Surgical System - Percutaneous Application (7D Flash Frame)?

7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is 7D Surgical. The 510(k) number is K220522.

When did 7D Surgical System - Percutaneous Application (7D Flash Frame) receive FDA 510(k) clearance?

7D Surgical System - Percutaneous Application (7D Flash Frame) received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220522.

Who is the listed applicant for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

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

What is the FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame) is OLO.

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