K161045 is an FDA 510(k) clearance for the Monoject. This device is classified as a Enteral Syringes With Enteral Specific Connectors (Class II - Special Controls, product code PNR).
Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on June 17, 2016, 65 days after receiving the submission on April 13, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors..
| 510(k) Number | K161045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2016 |
| Decision Date | June 17, 2016 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PNR — Enteral Syringes With Enteral Specific Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors. |