Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EndoTool IV 1.10

K-Number: K200443 · 2020-03-17

ApplicantMonarch Medical Technologies, LLC
Decision Date2020-03-17
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EndoTool IV 1.10 is a medical device manufactured by Monarch Medical Technologies, LLC. It received FDA 510(k) clearance on 2020-03-17 under approval number K200443. 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 1.10?

EndoTool IV 1.10 is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Monarch Medical Technologies, LLC. The 510(k) number is K200443.

When was EndoTool IV 1.10 approved by the FDA?

EndoTool IV 1.10 received FDA 510(k) clearance on 2020-03-17, under approval number K200443.

What company makes EndoTool IV 1.10?

EndoTool IV 1.10 is manufactured by Monarch Medical Technologies, LLC.

What is the FDA product code for EndoTool IV 1.10?

The FDA product code for EndoTool IV 1.10 is NDC.

Other Devices by Monarch Medical Technologies, LLC

K201619EndoTool IV System K211160EndoTool SubQ 2.1

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

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.

↑