FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K171857 |
Amsino International, Inc. |
AMSure« Enteral Feeding Syringe with ENFit Tip |
03/30/2018 |
K222772 |
Anhui Tiankang Medical Technology Co., Ltd. |
Oral/Enteral Syringe with ENFit connector |
08/17/2023 |
K231300 |
Cair LG |
Nutricair Enteral Syringe with ENFit |
10/06/2023 |
K142128 |
COVIDIEN |
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR |
02/23/2015 |
K161045 |
Covidien |
Monoject |
06/17/2016 |
K160419 |
COVIDIEN |
Monoject Enteral Feeding Syringe with ENFit Connector |
05/12/2016 |
K161963 |
COVIDIEN |
Monoject Enteral Syringe with ENFit Connector |
09/01/2016 |
K170672 |
International Medical Industries, Inc. |
Tamper Evident Cap For use with ENFit Syringes |
10/06/2017 |
K170371 |
INTERVENE Group Limited |
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 |
10/20/2017 |
K190502 |
Jiangsu Caina Medical Co., Ltd. |
ENFit Oral / Enteral Syringe |
08/06/2019 |
K211593 |
Jiangsu Caina Medical Co., Ltd. |
Enteral Pump Syringe |
09/30/2021 |
K222155 |
Jiangsu Caina Medical Co., Ltd. |
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector |
09/16/2022 |
K182649 |
Jiangsu Kangbao Medical Equipment Co., Ltd |
Enteral Feeding Syringes with Enfit Connectors |
11/09/2018 |
K181426 |
Jiangsu Micsafe Medical Technology Co., Ltd |
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) |
10/11/2018 |
K200557 |
Jiangsu Shenli Medical Production Co., Ltd |
Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) |
09/28/2020 |
K161979 |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
ENFit enteral syringe |
03/22/2017 |
K161811 |
Medela, Inc. |
Medela Low Dose Enteral Syringe |
02/15/2017 |
K202285 |
Medline Industries, Inc. |
Medline ENfit OTC Feeding Syringe |
10/09/2020 |
K161039 |
NeoMed, Inc. |
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) |
06/17/2016 |
K143344 |
NEOMED, INC. |
NeoMed NeoConnect Enteral Syringes with ENFit Connector |
04/09/2015 |
K152857 |
NEOMED, INC. |
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps |
12/17/2015 |
K183540 |
NeoMed, Inc. |
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) |
04/30/2019 |
K210621 |
Ningbo Tianyi Medical Appliance Co., Ltd. |
Oral/Enteral Syringe |
04/28/2021 |
K211025 |
Ningbo Tianyi Medical Appliance Co., Ltd. |
Oral/Enteral Syringe with ENFit connector |
06/30/2021 |
K161141 |
PENTAFERTE ITALIA S.R.L. |
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT |
03/22/2017 |
K211661 |
Pentaferte Italia S.R.L. |
ENFit enteral syringes (NUTRIFIT) |
02/28/2022 |
K192179 |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Oral/Enteral Syringe |
05/01/2020 |
K203410 |
Shantou Wealy Medical Instrument Co., Ltd. |
ENFit Disposable Enteral Syringe |
06/28/2021 |
K203613 |
Shantou Wealy Medical Instrument Co., Ltd. |
ENFit Reusable Enteral Syringe |
08/27/2021 |
K193657 |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Disposable Enteral Feeding Syringe with Enfit Connector |
09/12/2020 |
K160855 |
U&U MEDICAL TECHNOLOGY CO.,LTD |
U&U Enteral Syringe |
11/22/2016 |
K162188 |
VR MEDICAL TECHNOLOGY |
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) |
09/22/2016 |