510(k) K203410

Device: ENFit Disposable Enteral Syringe
Applicant: Shantou Wealy Medical Instrument Co.,Ltd
510(k) number: K203410
Product code: PNR
Decision: Substantially Equivalent (SESE)
Decision date: 2021-06-28
Date received: 2020-11-19
Regulation: 876.5980
Classification name: Enteral Syringes With Enteral Specific Connectors
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Yang Songling
Address: North Jinhuan Rd. (Near Qishan Mid-School), Shantou China Shantou CN 515064 515064

FDA Registration Numbers

3006795797
3006271008
3004099493
1423537
3005202235
3017509841
1017768
3005515211
3005669815
3007590959
2029275
3009742443
3011270181
1530671
3035455509
3008311916
3000209995
3008432385
3038294399
1423662
3014456066
8020785
1921846
3005674464
3004756837
3014570560
3013298431
1419937
3010331226
3014656668
3025432964
3012039263
1061927
3023228837
1217831
3027977504
3010131137
3014662855
3012421607
2080225
3013557562
9612030
3005934752
3005670221
3007441619
3042370483
3036722184
2025917
1915484

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PNR

510(k)	Device	Applicant	Decision date
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
K251585	Profoject Enteral Feeding Syringe	CMT Health PTE., Ltd.	2025-07-18
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
K231300	Nutricair Enteral Syringe with ENFit	Cair Lgl	2023-10-06
K222772	Oral/Enteral Syringe with ENFit connector	Anhui Tiankang Medical Technology Co., Ltd.	2023-08-17
K211661	ENFit enteral syringes (NUTRIFIT)	Pentaferte Italia S.R.L.	2022-02-28
K211593	Enteral Pump Syringe	Jiangsu Caina Medical Co.,Ltd	2021-09-30
K203613	ENFit Reusable Enteral Syringe	Shantou Wealy Medical Instrument Co.,Ltd	2021-08-27
K211025	Oral/Enteral Syringe with ENFit connector	Ningbo Tianyi Medical Appliance Co., Ltd.	2021-06-30
K210621	Oral/Enteral Syringe	Ningbo Tianyi Medical Appliance Co., Ltd.	2021-04-28
K202285	Medline ENfit OTC Feeding Syringe	Medline Industries, Inc.	2020-10-09
K200557	Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)	Jiangsu Shenli Medical Production Co., Ltd.	2020-09-28
K193657	Disposable Enteral Feeding Syringe with Enfit Connector	Shinva Ande Healthcare Apparatus Co., Ltd.	2020-09-12
K190502	ENFit Oral / Enteral Syringe	Jiangsu Caina Medical Co.,Ltd	2019-08-06
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