K161003 is an FDA 510(k) clearance for the EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube 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 Corporation (Marlboro, US). The FDA issued a Cleared decision on June 17, 2016, 67 days after receiving the submission on April 11, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..
| 510(k) Number | K161003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | April 11, 2016 |
| Decision Date | June 17, 2016 |
| Days to Decision | 67 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. |