K203613 is an FDA 510(k) clearance for the ENFit Reusable Enteral Syringe. This device is classified as a Enteral Syringes With Enteral Specific Connectors (Class II - Special Controls, product code PNR).
Submitted by Shantou Wealy Medical Instrument Co.,Ltd (Shantou, CN). The FDA issued a Cleared decision on August 27, 2021, 260 days after receiving the submission on December 10, 2020.
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 | K203613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | August 27, 2021 |
| Days to Decision | 260 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. |