Cleared Traditional

EndoTool SubQ

K142918 · Monarch Medical Technologies · General Hospital
Apr 2015
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K142918 is an FDA 510(k) clearance for the EndoTool SubQ, 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 April 24, 2015, 199 days after receiving the submission on October 7, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K142918 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2014
Decision Date April 24, 2015
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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