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Oral/Enteral Syringe with ENFit connector

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222772

by Anhui Tiankang Medical Technology Co., Ltd.

Identifiers

510(k) Number
K222772 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 Oral/Enteral Syringe with ENFit connector is a medical device used for enteral feeding. It is classified as a Class 2 device and is regulated under 21 CFR 876.5980. The device is designed for use in gastroenterology and urology.

The syringe is supplied with an ENFit connector and is intended for single-use. It is available in various sizes and is stored in a sterile environment. The device has been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K222772.

Frequently asked questions

What is the Oral/Enteral Syringe with ENFit connector used for?

The Oral/Enteral Syringe with ENFit connector is used for enteral feeding in gastroenterology and urology.

Is the Oral/Enteral Syringe with ENFit connector sterile?

Yes, the syringe is stored in a sterile environment and is intended for single-use.

What sizes is the Oral/Enteral Syringe with ENFit connector available in?

The syringe is available in various sizes to accommodate different patient needs.

What regulatory clearance has the Oral/Enteral Syringe with ENFit connector received?

The device has been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K222772.

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: Oral/Enteral Syringe with ENFit connector (K222772) — FDA 510 (k ..., K222772 FDA 510(k) - Oral/Enteral Syringe with ENFit connector, K222772 - Oral/Enteral Syringe with ENFit connector FDA 510 (k ..., Oral/Enteral Syringe with ENFit connector — FDA K222772

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anhui Tiankang Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K222772 24 fields · synced Oct 6, 2026