K181760 is an FDA 510(k) clearance for the Transit-Pellets, a System, Gastrointestinal Motility (electrical) (Class II — Special Controls, product code FFX), submitted by Medifactia AB (Gothenburg, SE). The FDA issued a Cleared decision on August 8, 2019, 401 days after receiving the submission on July 3, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K181760 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2018 |
| Decision Date | August 08, 2019 |
| Days to Decision | 401 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 |