FDA 510(k)

EndoTool IV (3.1)

K-Number: K241088 · 2024-12-11

Decision Date2024-12-11

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EndoTool IV (3.1) is the device name listed in this FDA 510(k) record. The listed applicant is Monarch Medical Technologies. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K241088. 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 (3.1)?

EndoTool IV (3.1) is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Monarch Medical Technologies. The 510(k) number is K241088.

When did EndoTool IV (3.1) receive FDA 510(k) clearance?

EndoTool IV (3.1) received FDA 510(k) clearance on 2024-12-11, under 510(k) number K241088.

Who is the listed applicant for EndoTool IV (3.1)?

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

What is the FDA product code for EndoTool IV (3.1)?

The FDA product code for EndoTool IV (3.1) is NDC.

Other records listing Monarch Medical Technologies 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.

K211160EndoTool SubQ 2.1 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 K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed

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.