Cleared Special

IntelliCartTM System

K190789 · Dornoch Medical Systems · General & Plastic Surgery
Apr 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K190789 is an FDA 510(k) clearance for the IntelliCartTM System, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Dornoch Medical Systems (Riverside, US). The FDA issued a Cleared decision on April 24, 2019, 28 days after receiving the submission on March 27, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K190789 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2019
Decision Date April 24, 2019
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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