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 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 2020-08-07 under 510(k) 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. The listed applicant is Monarch Medical Technologies, LLC. The 510(k) number is K201619.

When did EndoTool IV System receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoTool IV System?

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 IV System?

The FDA product code for EndoTool IV System 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)K211160EndoTool SubQ 2.1 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.