510(k) K222155
- Device
- Single Use O-ring Gasket Syringe With ENFit Connector, Reusable O-ring Gasket Syringe With ENFit Connector
- Applicant
- Jiangsu Caina Medical Co., Ltd.
- 510(k) number
- K222155
- Product code
- PNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-16
- Date received
- 2022-07-20
- Regulation
- 876.5980
- Classification name
- Enteral Syringes With Enteral Specific Connectors
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Clearance type
- Traditional
- Third party reviewed
- No
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 |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases