Nutricair Enteral Syringe with ENFit
FDA 510(k) clearance K231300 · decided 2023-10-06
Clearance details
- K-number
- K231300
- Device name
- Nutricair Enteral Syringe with ENFit
- Applicant
- Cair Lgl
- Decision
- Substantially Equivalent
- Date received
- 2023-05-04
- Decision date
- 2023-10-06
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lissieu, FR
- 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 |
| 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 |
| Medline ENfit OTC Feeding Syringe (K202285) | Medline Industries, Inc. | 2020-10-09 |
Recalls involving this device
No recalls on record reference this clearance.