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FDA 510(k)

TransEnterix Senhance Surgical System

K-Number: K180163 · 2018-05-25

ApplicantTransenterix, Inc.
Decision Date2018-05-25
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TransEnterix Senhance Surgical 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 2018-05-25 under 510(k) number K180163. 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 TransEnterix Senhance Surgical System?

TransEnterix Senhance Surgical System is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Transenterix, Inc.. The 510(k) number is K180163.

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

TransEnterix Senhance Surgical System received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180163.

Who is the listed applicant for TransEnterix Senhance Surgical 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 TransEnterix Senhance Surgical System?

The FDA product code for TransEnterix Senhance Surgical 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

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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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