Cleared Traditional

EndoTool IV (3.1)

K241088 · Monarch Medical Technologies · Chemistry
Dec 2024
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K241088 is an FDA 510(k) clearance for the EndoTool IV (3.1), a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Monarch Medical Technologies (Charlotte, US). The FDA issued a Cleared decision on December 11, 2024, 236 days after receiving the submission on April 19, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K241088 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2024
Decision Date December 11, 2024
Days to Decision 236 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890