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FDA 510(k)

EndoTool IV System

K-Number: K201619 · 2020-08-07

ApplicantMonarch Medical Technologies, LLC
Decision Date2020-08-07
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EndoTool IV System is a medical device manufactured by Monarch Medical Technologies, LLC. It received FDA 510(k) clearance on 2020-08-07 under approval number K201619. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoTool IV System?

EndoTool IV System is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Monarch Medical Technologies, LLC. The 510(k) number is K201619.

When was EndoTool IV System approved by the FDA?

EndoTool IV System received FDA 510(k) clearance on 2020-08-07, under approval number K201619.

What company makes EndoTool IV System?

EndoTool IV System is manufactured by Monarch Medical Technologies, LLC.

What is the FDA product code for EndoTool IV System?

The FDA product code for EndoTool IV System is NDC.

Other Devices by Monarch Medical Technologies, LLC

K200443EndoTool IV 1.10 K211160EndoTool SubQ 2.1

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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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