FDA 510(k)

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)

K-Number: K170644 · 2017-09-11

Decision Date2017-09-11

Product CodeNAY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) 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 2017-09-11 under 510(k) number K170644. 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 S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)?

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K170644.

When did da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) receive FDA 510(k) clearance?

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170644.

Who is the listed applicant for da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)?

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 S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)?

The FDA product code for da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) 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 NCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairRECRUITING 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

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.