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FDA 510(k)

Senhance Ultrasonic System

K-Number: K254192 · 2026-05-12

ApplicantAsensus Surgical
Decision Date2026-05-12
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03385109The TransEnterix European Patient RegistryTERMINATEDNCT07081828The Asensus Paediatric Robotic RegistryTERMINATED

Other records listing Asensus Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233866Senhance Surgical SystemK223095Senhance Surgical SystemK220889Senhance Surgical SystemK212054Senhance Surgical SystemK211325Senhance Surgical System

Related Devices (Code: NAY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive SurgicalK253986da 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.K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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