PNR — Enteral Syringes With Enteral Specific Connectors Class II
FDA product code PNR covers "Enteral Syringes With Enteral Specific Connectors", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252483 | chirana t.injecta,a.s | Enteral Syringe (20ml, 60ml) | July 1, 2026 |
| K253268 | cmt health pte | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding | April 8, 2026 |
| 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 |
| 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 |