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FDA 510(k)

SureForm 60 and SureForm 60 Reloads

K-Number: K173721 · 2018-07-05

ApplicantIntuitive Surgical
Decision Date2018-07-05
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SureForm 60 and SureForm 60 Reloads is a medical device manufactured by Intuitive Surgical. It received FDA 510(k) clearance on 2018-07-05 under approval number K173721. 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 SureForm 60 and SureForm 60 Reloads?

SureForm 60 and SureForm 60 Reloads is a medical device that received FDA 510(k) clearance on 2018-07-05. It is manufactured by Intuitive Surgical. The 510(k) number is K173721.

When was SureForm 60 and SureForm 60 Reloads approved by the FDA?

SureForm 60 and SureForm 60 Reloads received FDA 510(k) clearance on 2018-07-05, under approval number K173721.

What company makes SureForm 60 and SureForm 60 Reloads?

SureForm 60 and SureForm 60 Reloads is manufactured by Intuitive Surgical.

What is the FDA product code for SureForm 60 and SureForm 60 Reloads?

The FDA product code for SureForm 60 and SureForm 60 Reloads is NAY.

Other Devices by Intuitive Surgical

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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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