FDA.reportPublic FDA data

510(k) K140581

Device
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
Applicant
CEDIC S.R.L.
510(k) number
K140581
Product code
PIO  
Decision
Substantially Equivalent (SESE)
Decision date
2014-10-17
Date received
2014-03-06
Regulation
876.5980
Classification name
Enteral Specific Transition Connectors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROGER GRAY
Address
Piazza Albania 10 Rome IT 00153 00153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PIO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl2024-01-22
K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd2024-01-18
K220165Enteral Transition AdaptorGBUK Group, Ltd.2022-10-21
K162254Cedic Enteral ENFit Transition ConnectorsCedic S.R.L.2017-05-04
K151237Nutrisafe 2- ENFit AdaptorVygon2016-02-09
K151628Medline ENFit ConnectorsMedline Industries, Inc.2015-07-24
K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc.2015-06-09
K150010Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortCedic S.R.L.2015-04-02

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases