ENFit Oral / Enteral Syringe
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190502 FDA 510(k)
- FDA Product Code
- PNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ENFit Oral/Enteral Syringe is a syringe with enteral-specific connectors designed for the administration of oral or enteral nutrition. It features an ENFit connector, a standardized reverse-luer lock system, to ensure safe and secure attachment to enteral feeding tubes, minimizing the risk of misconnection with incompatible devices.
This device is intended for single-use in clinical settings such as gastroenterology and urology. Supplied sterile, it is classified as a Class II medical device under FDA regulations (510(k) clearance) and adheres to the Medical Device Directive (MDD). Available in multiple sizes (as referenced by FEI numbers), it requires proper storage in a clean, dry environment to maintain sterility and functionality.
Frequently asked questions
What clinical specialties is the ENFit Oral/Enteral Syringe primarily used in, and why is this important for clinicians?
The ENFit Oral/Enteral Syringe is designed for use in gastroenterology and urology specialties, as indicated by its advisory committee classification. This matters for clinicians because it ensures the device is optimized for procedures involving enteral feeding tubes, reducing the risk of misconnection with incompatible devices—critical for patient safety in these specialties.
Is the ENFit Oral/Enteral Syringe meant for repeated use, or is it single-use only? How does this affect its handling?
The device is intended for single-use only in clinical settings. This means each syringe should be discarded after one use to maintain sterility and prevent contamination, reducing the risk of infection or cross-transmission between patients.
How do I ensure the sterility of the ENFit Oral/Enteral Syringe before use, and what storage conditions are recommended?
The syringe is supplied sterile, so it should remain unopened until use. To preserve sterility, store it in a clean, dry environment away from direct sunlight or moisture. Avoid exposing it to extreme temperatures or contamination, as this could compromise its integrity before use.
What sizes or models of the ENFit Oral/Enteral Syringe are available, and how can I identify the correct one for my needs?
The device comes in multiple sizes, each identified by a unique FEI number (e.g., 3013557562, 3010331226, etc.). These numbers correspond to specific syringe volumes or configurations. Check the packaging or documentation for the correct FEI number matching your clinical requirements, such as the volume needed for enteral feeding.
What regulatory pathways does the ENFit Oral/Enteral Syringe follow, and how does this affect its availability in different markets?
The syringe has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it is legally marketed in the U.S. under FDA regulations and in the EU (or other MDD-compliant regions) under the respective directives. Its availability depends on these approvals, ensuring it meets safety and performance standards in regulated markets.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ENFit® Spritze | B. Braun, Enterale Ernährungsspritzen - Fresenius Kabi Global, ENFit connectors for enteral feeding - Medline
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190502 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd
- FDA Applicant
- Jiangsu Caina Medical Co.,Ltd
Sources (2)
- FDA 510(k) K190502 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026