ENFit enteral syringe
FDA 510(k) clearance K161979 · decided 2017-03-22
Clearance details
- K-number
- K161979
- Device name
- ENFit enteral syringe
- Applicant
- Jiangyin Caina Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-18
- Decision date
- 2017-03-22
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jiangyin, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Enteral Syringe (20ml, 60ml) (K252483) | Chirana T.Injecta,A.S. | 2026-07-01 |
| Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (K253268) | CMT Health PTE., Ltd. | 2026-04-08 |
| Profoject™ Enteral Feeding Syringe (K251585) | CMT Health PTE., Ltd. | 2025-07-18 |
| 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) (K243652) | Cardinalhealth | 2024-12-19 |
| Nutricair Enteral Syringe with ENFit (K231300) | Cair Lgl | 2023-10-06 |
| Oral/Enteral Syringe with ENFit connector (K222772) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| ENFit enteral syringes (NUTRIFIT) (K211661) | Pentaferte Italia S.R.L. | 2022-02-28 |
| Enteral Pump Syringe (K211593) | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 |
| ENFit Reusable Enteral Syringe (K203613) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 |
| Oral/Enteral Syringe with ENFit connector (K211025) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 |
| ENFit Disposable Enteral Syringe (K203410) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 |
| Oral/Enteral Syringe (K210621) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 |
Recalls involving this device
No recalls on record reference this clearance.