Cleared Special

IntraMarX 3D Radiopaque Marker

K201106 · Anx Robotica Corp · Gastroenterology & Urology
May 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K201106 is an FDA 510(k) clearance for the IntraMarX 3D Radiopaque Marker, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Anx Robotica Corp (Pleasanton, US). The FDA issued a Cleared decision on May 21, 2020, 27 days after receiving the submission on April 24, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.

Submission Details

510(k) Number K201106 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2020
Decision Date May 21, 2020
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FFX — System, Gastrointestinal Motility (electrical)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1725

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