510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201619Substantially Equivalent

EndoTool IV System

Monarch Medical Technologies, Charlotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201619 is the FDA 510(k) clearance record for EndoTool IV System, a class II device, cleared for Monarch Medical Technologies, LLC on under FDA product code NDC (Calculator, Drug Dose). FDA records list 6 510(k) clearances for Monarch Medical Technologies, LLC, from to . As of , FDA records show no recalls naming K201619.

Clearance record

Decision date
Received
(53 days to decision)
Product code
NDC Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd., Suite N, Charlotte NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDC

Trailing 12 months
4 clearances under product code NDC in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NDC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260