Medela Low Dose Enteral Syringe
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K161811 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 Medela Low Dose Enteral Syringe is a manual fluid delivery device designed for small-volume enteral drug delivery. It features an ENFit connector system that prevents unwanted liquid transfer during connection and disconnection from feeding tubes, improving delivery accuracy.
This sterile, disposable syringe is supplied in cases of 100 units and is compatible with most syringe pumps. It has a closed cap for secure transportation or warming, a smooth plunger for minimal effort operation, and a large, visible number scale for easy reading. The device has received FDA 510(k) clearance with K number K161811.
Frequently asked questions
What is the Medela Low Dose Enteral Syringe used for?
The Medela Low Dose Enteral Syringe is a manual fluid delivery device designed specifically for small-volume enteral drug delivery. It features an ENFit connector system that prevents unwanted liquid transfer during connection and disconnection from feeding tubes, improving delivery accuracy.
How is the Medela Low Dose Enteral Syringe supplied and what are its key features?
This sterile, disposable syringe is supplied in cases of 100 units and is compatible with most syringe pumps. It has a closed cap for secure transportation or warming, a smooth plunger for minimal effort operation, and a large, visible number scale for easy reading.
Is the Medela Low Dose Enteral Syringe reusable or single-use?
The Medela Low Dose Enteral Syringe is a sterile, disposable device designed for single-use only. It should not be reused to ensure patient safety and maintain sterility.
What regulatory clearance has the Medela Low Dose Enteral Syringe received?
The device has received FDA 510(k) clearance with K number K161811, which means it has been determined to be substantially equivalent to predicate devices already on the market for the same intended use.
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® Syringes - Secure & Versatile | Medela, Medela Syringes with ENFit® Connectors, Medela 1 mL ENFit Low Dose Enteral Feeding Syringes, Case of 100, Medela Low Dose Enteral Syringe (K161811) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161811 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, Inc.
Sources (1)
- FDA 510(k) K161811 24 fields · synced Sep 26, 2026