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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 a medical device manufactured by Transenterix, Inc.. It received FDA 510(k) clearance on 2017-10-13 under approval 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. It is manufactured by Transenterix, Inc.. The 510(k) number is K171120.

When was Senhance Surgical Robotic System approved by the FDA?

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

What company makes Senhance Surgical Robotic System?

Senhance Surgical Robotic System is manufactured by Transenterix, Inc..

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

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

Other Devices by Transenterix, Inc.

K183098Senhance Surgical System K181517Senhance Surgical System K180163TransEnterix Senhance Surgical System K192877Senhance Surgical System K191482Senhance Surgical System K182421Senhance Ultrasonic 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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