K201106 is an FDA 510(k) clearance for the IntraMarX 3D Radiopaque Marker. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K201106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FFX - System, Gastrointestinal Motility (electrical) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |