Skip to content

Cedic Enteral Distal End Enfit Transition Connector

by Cedic S.R.L.

510(k) K140581

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140581 Date17 Oct 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port
510(k) Number
FDA Product Code
PIO
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cedic Enteral Distal End Enfit Transition Connector is an enteral specific transition connector. It is designed to connect an enteral giving set with an ENFit connector to an enteral catheter.

This device is identified under FDA 510(k) number K140581 and is classified under regulation number 876.5980. It is manufactured by Cedic S.R.L. and falls under the gastroenterology and urology medical specialty categories.

Other devices from Cedic S.R.L.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Cedic Enteral Distal End ENFit Transition Connector?

    This device is specifically designed to serve as a transition interface, allowing for the secure connection between an enteral giving set equipped with an ENFit connector and an enteral catheter.

  • What is the regulatory status of this connector?

    The Cedic Enteral Distal End ENFit Transition Connector is identified under FDA 510(k) number K140581. It is classified under regulation number 876.5980 within the gastroenterology and urology medical specialty categories.

  • Who is the manufacturer of this enteral transition connector?

    This device is manufactured by Cedic S.R.L., which is based in Rome, Italy, and is the applicant associated with the FDA 510(k) clearance for this product line.