FDA 510(k)

da Vinci Xi Surgical System, da Vinci X Surgical System

K-Number: K192803 · 2020-04-29

Decision Date2020-04-29

Product CodeNAY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

da Vinci Xi Surgical System, da Vinci X Surgical System is a medical device manufactured by Intuitive Surgical. It received FDA 510(k) clearance on 2020-04-29 under approval number K192803. 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 da Vinci Xi Surgical System, da Vinci X Surgical System?

da Vinci Xi Surgical System, da Vinci X Surgical System is a medical device that received FDA 510(k) clearance on 2020-04-29. It is manufactured by Intuitive Surgical. The 510(k) number is K192803.

When was da Vinci Xi Surgical System, da Vinci X Surgical System approved by the FDA?

da Vinci Xi Surgical System, da Vinci X Surgical System received FDA 510(k) clearance on 2020-04-29, under approval number K192803.

What company makes da Vinci Xi Surgical System, da Vinci X Surgical System?

da Vinci Xi Surgical System, da Vinci X Surgical System is manufactured by Intuitive Surgical.

What is the FDA product code for da Vinci Xi Surgical System, da Vinci X Surgical System?

The FDA product code for da Vinci Xi Surgical System, da Vinci X Surgical 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: 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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Intuitive Surgical

K152892da Vinci Xi Surgical System K173721SureForm 60 and SureForm 60 Reloads K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 K182643IRIS 1.0 System K182188Ion Endoluminal System ; Flexision Biopsy Needle K183224SureForm 45, SureForm 45 Reloads

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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.