K191844 is an FDA 510(k) clearance for the Fidmi Low Profile Enteral Feeding Device, a Tube, Gastro-enterostomy (Class II — Special Controls, product code KGC), submitted by Fidmi Medical, Ltd. (Caesarea Business Park, Caesarea, IL). The FDA issued a Cleared decision on September 30, 2019, 83 days after receiving the submission on July 9, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K191844 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 2019 |
| Decision Date | September 30, 2019 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGC — Tube, Gastro-enterostomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |