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FDA 510(k)

IS4000 Stapler 30 Instrument and Stapler 30 Reloads

K-Number: K152421 · 2016-03-04

ApplicantIntuitive Surgical, Inc.
Decision Date2016-03-04
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IS4000 Stapler 30 Instrument and Stapler 30 Reloads is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K152421. 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 IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

IS4000 Stapler 30 Instrument and Stapler 30 Reloads is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K152421.

When was IS4000 Stapler 30 Instrument and Stapler 30 Reloads approved by the FDA?

IS4000 Stapler 30 Instrument and Stapler 30 Reloads received FDA 510(k) clearance on 2016-03-04, under approval number K152421.

What company makes IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

IS4000 Stapler 30 Instrument and Stapler 30 Reloads is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

The FDA product code for IS4000 Stapler 30 Instrument and Stapler 30 Reloads is NAY.

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 K151794da Vinci Xi Surgical System

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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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