K222000 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 (Stockholm, SE). The FDA issued a Cleared decision on January 18, 2023, 195 days after receiving the submission on July 7, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K222000 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 07, 2022 |
| Decision Date | January 18, 2023 |
| Days to Decision | 195 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 |