K150679 is an FDA 510(k) clearance for the EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector. This device is classified as a Gastrointestinal Tubes With Enteral Specific Connectors (Class II - Special Controls, product code PIF).
Submitted by Boston Scientific Corp (Marlborough, US). The FDA issued a Cleared decision on May 29, 2015, 73 days after receiving the submission on March 17, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..
| 510(k) Number | K150679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | March 17, 2015 |
| Decision Date | May 29, 2015 |
| Days to Decision | 73 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. |