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FDA 510(k)

SureForm 45, SureForm 45 Reloads

K-Number: K183224 · 2019-01-18

ApplicantIntuitive Surgical
Decision Date2019-01-18
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SureForm 45, SureForm 45 Reloads is a medical device manufactured by Intuitive Surgical. It received FDA 510(k) clearance on 2019-01-18 under approval number K183224. 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 45, SureForm 45 Reloads?

SureForm 45, SureForm 45 Reloads is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Intuitive Surgical. The 510(k) number is K183224.

When was SureForm 45, SureForm 45 Reloads approved by the FDA?

SureForm 45, SureForm 45 Reloads received FDA 510(k) clearance on 2019-01-18, under approval number K183224.

What company makes SureForm 45, SureForm 45 Reloads?

SureForm 45, SureForm 45 Reloads is manufactured by Intuitive Surgical.

What is the FDA product code for SureForm 45, SureForm 45 Reloads?

The FDA product code for SureForm 45, SureForm 45 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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