Cleared Traditional

CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT

K140581 · Cedic S.R.L. · Gastroenterology & Urology

Oct 2014

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K140581 is an FDA 510(k) clearance for the CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT, a Enteral Specific Transition Connectors (Class II — Special Controls, product code PIO), submitted by Cedic S.R.L. (Rome, IT). The FDA issued a Cleared decision on October 17, 2014, 225 days after receiving the submission on March 6, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K140581 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2014
Decision Date	October 17, 2014
Days to Decision	225 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PIO — Enteral Specific Transition Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors.