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 the device name listed in this FDA 510(k) record. The listed applicant is Monarch Medical Technologies, LLC. It received FDA 510(k) clearance on 2021-10-28 under 510(k) 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. The listed applicant is Monarch Medical Technologies, LLC. The 510(k) number is K211160.

When did EndoTool SubQ 2.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoTool SubQ 2.1?

The FDA 510(k) record lists Monarch Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoTool SubQ 2.1?

The FDA product code for EndoTool SubQ 2.1 is NDC.

Other records listing Monarch Medical Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241088EndoTool IV (3.1)K201619EndoTool IV System K200443EndoTool IV 1.10

Related Devices (Code: NDC)

K254102GlucommanderGlytec, LLC K260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic Minimed K253281UpDocUpdoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.