PNR — Enteral Syringes With Enteral Specific Connectors Class II
Classification Details
- Product Code
- PNR
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251585 | cmt health pte | Profoject Enteral Feeding Syringe | July 18, 2025 |
| K243652 | cardinalhealth | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syring | December 19, 2024 |
| K231300 | cair lgl | Nutricair Enteral Syringe with ENFit | October 6, 2023 |
| K222772 | anhui tiankang medical technology co | Oral/Enteral Syringe with ENFit connector | August 17, 2023 |
| K222155 | jiangsu caina medical co | Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket sy | September 16, 2022 |
| K211661 | pentaferte italia | ENFit enteral syringes (NUTRIFIT) | February 28, 2022 |
| K211593 | jiangsu caina medical co | Enteral Pump Syringe | September 30, 2021 |
| K203613 | shantou wealy medical instrument co | ENFit Reusable Enteral Syringe | August 27, 2021 |
| K211025 | ningbo tianyi medical appliance co | Oral/Enteral Syringe with ENFit connector | June 30, 2021 |
| K203410 | shantou wealy medical instrument co | ENFit Disposable Enteral Syringe | June 28, 2021 |
| K210621 | ningbo tianyi medical appliance co | Oral/Enteral Syringe | April 28, 2021 |
| K202285 | medline industries | Medline ENfit OTC Feeding Syringe | October 9, 2020 |
| K200557 | jiangsu shenli medical production co | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | September 28, 2020 |
| K193657 | shinva ande healthcare apparatus co | Disposable Enteral Feeding Syringe with Enfit Connector | September 12, 2020 |
| K190502 | jiangsu caina medical co | ENFit Oral / Enteral Syringe | August 6, 2019 |
| K183540 | neomed | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/E | April 30, 2019 |
| K182649 | jiangsu kangbao medical equipment co | Enteral Feeding Syringes with Enfit Connectors | November 9, 2018 |
| K181426 | jiangsu micsafe medical technology co | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 m | October 11, 2018 |
| K171857 | amsino international | AMSure® Enteral Feeding Syringe with ENFit Tip | March 30, 2018 |
| K170371 | intervene group limited | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, | October 20, 2017 |