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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 a medical device manufactured by Asensus Surgical. It received FDA 510(k) clearance on 2026-05-12 under approval 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. It is manufactured by Asensus Surgical. The 510(k) number is K254192.

When was Senhance Ultrasonic System approved by the FDA?

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

What company makes Senhance Ultrasonic System?

Senhance Ultrasonic System is manufactured by Asensus Surgical.

What is the FDA product code for Senhance Ultrasonic System?

The FDA product code for Senhance Ultrasonic System is NAY.

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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