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FDA 510(k)

EndoTool IV (3.1)

K-Number: K241088 · 2024-12-11

ApplicantMonarch Medical Technologies
Decision Date2024-12-11
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EndoTool IV (3.1) is a medical device manufactured by Monarch Medical Technologies. It received FDA 510(k) clearance on 2024-12-11 under approval 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. It is manufactured by Monarch Medical Technologies. The 510(k) number is K241088.

When was EndoTool IV (3.1) approved by the FDA?

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

What company makes EndoTool IV (3.1)?

EndoTool IV (3.1) is manufactured by Monarch Medical Technologies.

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

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

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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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