FDA 510(k)

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System

K-Number: K222839 · 2023-03-16

Decision Date2023-03-16

Product CodeNAY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System 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 2023-03-16 under 510(k) number K222839. 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 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System?

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K222839.

When did EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System receive FDA 510(k) clearance?

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System received FDA 510(k) clearance on 2023-03-16, under 510(k) number K222839.

Who is the listed applicant for EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System?

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 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System?

The FDA product code for EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 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.

NCT04403022da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresACTIVE_NOT_RECRUITING NCT05867927GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsRECRUITING NCT06084208Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTCOMPLETED NCT06308120A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBACTIVE_NOT_RECRUITING NCT06923774European Real-World Registry for Use of the Ion Endoluminal SystemRECRUITING NCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairRECRUITING

Other records listing Intuitive Surgical, Inc. as applicant

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000 K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging System K253986da Vinci Force Feedback Instruments K253978Universal Seal (5-12 mm)

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Related Devices (Code: NAY)

K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive Surgical K254192Senhance Ultrasonic SystemAsensus Surgical K253986da 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.