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FDA 510(k)

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

K-Number: K242427 · 2025-04-01

ApplicantIntuitive Surgical, Inc.
Decision Date2025-04-01
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-04-01 under approval number K242427. 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 (IS4000); da Vinci X Surgical System (IS4200)?

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is a medical device that received FDA 510(k) clearance on 2025-04-01. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K242427.

When was da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) approved by the FDA?

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) received FDA 510(k) clearance on 2025-04-01, under approval number K242427.

What company makes da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)?

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)?

The FDA product code for da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is NAY.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

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: 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)

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

View all 107 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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