K191784 is an FDA 510(k) clearance for the Gabriel Feeding Tube with Balloon, and EnFit Connector. This device is classified as a Gastrointestinal Tubes With Enteral Specific Connectors (Class II - Special Controls, product code PIF).
Submitted by Syncro Medical Innovations, Inc. (Macon, US). The FDA issued a Cleared decision on November 15, 2019, 135 days after receiving the submission on July 3, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..
| 510(k) Number | K191784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | July 03, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PIF - Gastrointestinal Tubes With Enteral Specific Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | To Facilitate Enteral Specific Connections. |