K180708 is an FDA 510(k) clearance for the Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit. This device is classified as a Gastrointestinal Tubes With Enteral Specific Connectors (Class II - Special Controls, product code PIF).
Submitted by Xeridiem Medical Devices, A Spectrum Plastics Group Company (Tucson, US). The FDA issued a Cleared decision on October 18, 2018, 213 days after receiving the submission on March 19, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..
| 510(k) Number | K180708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 19, 2018 |
| Decision Date | October 18, 2018 |
| Days to Decision | 213 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. |