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FDA 510(k)

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

K-Number: K170644 · 2017-09-11

ApplicantIntuitive Surgical, Inc.
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 a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2017-09-11 under approval 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. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K170644.

When was da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) approved by the FDA?

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

What company makes 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 manufactured by Intuitive Surgical, Inc..

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

NCT06608485 A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures RECRUITING

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

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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.

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