FDA Product Code
FDA Product Code PNR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | 2026-07-01 | Traditional | PDF ↗ |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K251585 | Profoject Enteral Feeding Syringe | CMT Health PTE., Ltd. | 2025-07-18 | Traditional | PDF ↗ |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth | 2024-12-19 | Special | PDF ↗ |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | 2023-10-06 | Traditional | PDF ↗ |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | Traditional | PDF ↗ |
| K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | 2022-02-28 | Traditional | PDF ↗ |
| K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 | Traditional | PDF ↗ |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 | Traditional | PDF ↗ |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 | Traditional | PDF ↗ |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 | Traditional | PDF ↗ |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 | Traditional | PDF ↗ |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | 2020-10-09 | Traditional | PDF ↗ |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 | Traditional | PDF ↗ |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 | Traditional | PDF ↗ |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd | 2019-08-06 | Traditional | PDF ↗ |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | Neomed, Inc. | 2019-04-30 | Traditional | PDF ↗ |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2018-11-09 | Traditional | PDF ↗ |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2018-10-11 | Traditional | PDF ↗ |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. | 2018-03-30 | Traditional | PDF ↗ |
| K170371 | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe | Intervene Group Limited | 2017-10-20 | Traditional | PDF ↗ |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | International Medical Industries, Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | Pentaferte Italia S.R.L. | 2017-03-22 | Traditional | PDF ↗ |
| K161979 | ENFit enteral syringe | Jiangyin Caina Technology Co., Ltd. | 2017-03-22 | Traditional | PDF ↗ |
| K161811 | Medela Low Dose Enteral Syringe | Medela, Inc. | 2017-02-15 | Traditional | PDF ↗ |
| K160855 | U&U Enteral Syringe | U&U Medical Technology Co, Ltd. | 2016-11-22 | Traditional | PDF ↗ |
| K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) | Vr Medical Technology | 2016-09-22 | Traditional | PDF ↗ |
| K161963 | Monoject Enteral Syringe with ENFit Connector | Covidien | 2016-09-01 | Traditional | PDF ↗ |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | Neomed, Inc. | 2016-06-17 | Traditional | PDF ↗ |
| K161045 | Monoject | Covidien | 2016-06-17 | Traditional | PDF ↗ |
| K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | Covidien | 2016-05-12 | Traditional | PDF ↗ |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | Neomed, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | Neomed, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K142128 | KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR | Covidien | 2015-02-23 | Traditional | PDF ↗ |
Product code PNR · Class II · Gastroenterology, Urology. Data: openFDA.