FDA 510(k)

Outlook Surgical Versa One System (8900139)

Número K: K241731 · 2025-08-11

Data da decisão2025-08-11

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Outlook Surgical Versa One System (8900139) is the device name listed in this FDA 510(k) record. The listed applicant is Resnent, LLC. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K241731. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Outlook Surgical Versa One System (8900139)?

Outlook Surgical Versa One System (8900139) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Resnent, LLC. The 510(k) number is K241731.

When did Outlook Surgical Versa One System (8900139) receive FDA 510(k) clearance?

Outlook Surgical Versa One System (8900139) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K241731.

Who is the listed applicant for Outlook Surgical Versa One System (8900139)?

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

What is the FDA product code for Outlook Surgical Versa One System (8900139)?

The FDA product code for Outlook Surgical Versa One System (8900139) is EOB.

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Fonte oficial

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