EndoTool IV 1.10— 510(k) K200443

Name: FDA 510(k) clearance K200443
Creator: U.S. Food and Drug Administration
Published: 2020-03-17

Substantially Equivalent

Monarch Medical Technologies, LLC

FDA 510(k) clearance K200443 for EndoTool IV 1.10, Substantially Equivalent on 2020-03-17. Applicant: Monarch Medical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Monarch Medical Technologies, LLC
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2020-02-24
Decision date: 2020-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.