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FDA 510(k)

Senhance Ultrasonic System

K-Number: K182421 · 2019-01-11

ApplicantTransenterix, Inc.
Decision Date2019-01-11
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Senhance Ultrasonic System is a medical device manufactured by Transenterix, Inc.. It received FDA 510(k) clearance on 2019-01-11 under approval number K182421. 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 2019-01-11. It is manufactured by Transenterix, Inc.. The 510(k) number is K182421.

When was Senhance Ultrasonic System approved by the FDA?

Senhance Ultrasonic System received FDA 510(k) clearance on 2019-01-11, under approval number K182421.

What company makes Senhance Ultrasonic System?

Senhance Ultrasonic System is manufactured by Transenterix, Inc..

What is the FDA product code for Senhance Ultrasonic System?

The FDA product code for Senhance Ultrasonic System is NAY.

Related Clinical Trials

NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT07508722 Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans NOT_YET_RECRUITING

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

Other Devices by Transenterix, Inc.

K171120Senhance Surgical Robotic System K183098Senhance Surgical System K181517Senhance Surgical System K180163TransEnterix Senhance Surgical System K192877Senhance Surgical System K191482Senhance Surgical System

View all 9 devices →

Related Devices (Code: NAY)

K162411da Vinci Xi 12 – 8 mm ReducerIntuitive Surgical, Inc. K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K152892da Vinci Xi Surgical SystemIntuitive Surgical K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. K152448da Vinci Single-Site Instrument and AccessoriesIntuitive 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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