FDA 510(k)

Senhance Ultrasonic System

Número K: K254192 · 2026-05-12

Data da decisão2026-05-12

Código do produtoNAY

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Senhance Ultrasonic System is the device name listed in this FDA 510(k) record. The listed applicant is Asensus Surgical. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K254192. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Senhance Ultrasonic System?

Senhance Ultrasonic System is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Asensus Surgical. The 510(k) number is K254192.

When did Senhance Ultrasonic System receive FDA 510(k) clearance?

Senhance Ultrasonic System received FDA 510(k) clearance on 2026-05-12, under 510(k) number K254192.

Who is the listed applicant for Senhance Ultrasonic System?

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

What is the FDA product code for Senhance Ultrasonic System?

The FDA product code for Senhance Ultrasonic System is NAY.

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Fonte oficial

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