K191844 is an FDA 510(k) clearance for the Fidmi Low Profile Enteral Feeding Device. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K191844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |