FDA 510(k)

Senhance Ultrasonic System

Номер K: K254192 · 2026-05-12

Дата решения2026-05-12

Код продуктаNAY

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NAY)

K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive Surgical K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.

Официальный источник

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