K-number	K211160
Device name	EndoTool SubQ 2.1
Applicant	Monarch Medical Technologies, LLC
Product code	NDC
Device class	Class II
Decision date	Oct 28, 2021
Decision	Substantially Equivalent
Regulation	868.1890

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Source

View the full FDA submission: accessdata.fda.gov

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EndoTool SubQ 2.1

Everything you need for a 510(k) submission. Nothing you don't.