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FDA 510(k)

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

K-Number: K253556 · 2026-01-16

ApplicantIntuitive Surgical, Inc.
Decision Date2026-01-16
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K253556. 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 SP Surgical System (SP1098); da Vinci E-200 Generator?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K253556.

When did da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator receive FDA 510(k) clearance?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253556.

Who is the listed applicant for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

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

What is the FDA product code for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

The FDA product code for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator 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.

NCT04403022da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresACTIVE_NOT_RECRUITINGNCT05867927GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsRECRUITINGNCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairENROLLING_BY_INVITATIONNCT06084208Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTCOMPLETEDNCT06308120A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBACTIVE_NOT_RECRUITINGNCT06923774European Real-World Registry for Use of the Ion Endoluminal SystemRECRUITING

Other records listing Intuitive Surgical, 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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 124 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.K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.K252675da Vinci SP Surgical System (SP1098)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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