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FDA 510(k)

Senhance Surgical Robotic System

K-Number: K171120 · 2017-10-13

ApplicantTransenterix, Inc.
Decision Date2017-10-13
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Senhance Surgical Robotic System is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K171120. 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 Surgical Robotic System?

Senhance Surgical Robotic System is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Transenterix, Inc.. The 510(k) number is K171120.

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

Senhance Surgical Robotic System received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171120.

Who is the listed applicant for Senhance Surgical Robotic System?

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

What is the FDA product code for Senhance Surgical Robotic System?

The FDA product code for Senhance Surgical Robotic 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 RegistryTERMINATED

Other records listing Transenterix, Inc. 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.

K202166Senhance Surgical SystemK200049Senhance Surgical SystemK192877Senhance Surgical SystemK191482Senhance Surgical SystemK182421Senhance Ultrasonic SystemK183098Senhance Surgical System

View all 9 devices →

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 SurgicalK254192Senhance Ultrasonic SystemAsensus 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.

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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