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FDA 510(k)

EndoTool SubQ 2.1

K-Number: K211160 · 2021-10-28

ApplicantMonarch Medical Technologies, LLC
Decision Date2021-10-28
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EndoTool SubQ 2.1 is a medical device manufactured by Monarch Medical Technologies, LLC. It received FDA 510(k) clearance on 2021-10-28 under approval number K211160. 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 SubQ 2.1?

EndoTool SubQ 2.1 is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Monarch Medical Technologies, LLC. The 510(k) number is K211160.

When was EndoTool SubQ 2.1 approved by the FDA?

EndoTool SubQ 2.1 received FDA 510(k) clearance on 2021-10-28, under approval number K211160.

What company makes EndoTool SubQ 2.1?

EndoTool SubQ 2.1 is manufactured by Monarch Medical Technologies, LLC.

What is the FDA product code for EndoTool SubQ 2.1?

The FDA product code for EndoTool SubQ 2.1 is NDC.

Other Devices by Monarch Medical Technologies, LLC

K201619EndoTool IV System K200443EndoTool IV 1.10

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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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