ENFit Disposable Enteral Syringe
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203410 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 Disposable Enteral Syringe is a single-use enteral syringe designed with an ENFit connector, a standardized reverse luer-lock system. It is classified as an enteral syringe with enteral-specific connectors, ensuring compatibility with enteral feeding devices and reducing the risk of misconnection.
This syringe is intended for use in enteral feeding applications within gastroenterology and urology settings. Supplied as a disposable item, it is not intended for reuse. The device is authorized under FDA 510K and MDR regulations, with a classification as a Class II medical device. Multiple registration numbers and FEI numbers are associated with its regulatory submissions.
Frequently asked questions
What clinical settings is the ENFit Disposable Enteral Syringe designed for, and why is the ENFit connector important?
The ENFit Disposable Enteral Syringe is specifically designed for use in enteral feeding applications, primarily within gastroenterology and urology settings. The ENFit connector is a standardized reverse luer-lock system that ensures compatibility with enteral feeding devices, reducing the risk of misconnection with incompatible tubing or accessories. This design minimizes errors that could compromise patient safety during feeding procedures.
Is the ENFit Disposable Enteral Syringe reusable, and if not, what does this mean for clinical workflows?
No, the ENFit Disposable Enteral Syringe is intended for single-use only and is not designed for reuse. This means each syringe must be discarded after a single use, which helps maintain sterility and hygiene in clinical settings. Clinicians should follow standard infection control protocols, ensuring a fresh syringe is used for each patient or feeding session to prevent contamination.
How is the ENFit Disposable Enteral Syringe authorized for use, and what does this mean for buyers?
The ENFit Disposable Enteral Syringe is authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), confirming it meets regulatory standards for safety and performance. It is classified as a Class II medical device, indicating it has undergone rigorous evaluation for its intended use in enteral feeding. Buyers can rely on this authorization to ensure compliance with global medical device regulations when procuring the product.
Are there different sizes or models available for the ENFit Disposable Enteral Syringe, and if so, how would I determine the right one for my needs?
While the provided data does not specify exact volume sizes or model variations (e.g., 10mL, 30mL, etc.), the ENFit Disposable Enteral Syringe is designed as a standardized enteral feeding tool. To determine the appropriate size, clinicians should refer to the manufacturer’s packaging or documentation, which typically lists available volumes. Common enteral syringes range from 10mL to 60mL, so verifying compatibility with your facility’s enteral feeding protocols is recommended.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203410 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
- FDA Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
Sources (2)
- FDA 510(k) K203410 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026