K191087 is an FDA 510(k) clearance for the IntraMarX Radiopaque Markers, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Anx Robotica Corp (Plano, US). The FDA issued a Cleared decision on December 18, 2019, 238 days after receiving the submission on April 24, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K191087 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 2019 |
| Decision Date | December 18, 2019 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |