Home / 510(k) Clearances / K140581

510(k) K140581

CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT by Cedic S.R.L. — Product Code PIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
March 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Specific Transition Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

Other clearances by Cedic S.R.L.

  • K181787 — Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes (April 25, 2019)
  • K190327 — ENConnect 40 mm Screw Cap to ENPlus Adapter (April 9, 2019)
  • K162254 — Cedic Enteral ENFit Transition Connectors (May 4, 2017)
  • K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (April 2, 2015)
  • K072652 — ENTERAL FEEDING SPIKE ADAPTER (January 18, 2008)
  • K042129 — F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LU (January 27, 2005)

Other clearances for product code PIO

  • K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (January 22, 2024)
  • K233190 — ENFit Adaptor (January 18, 2024)
  • K220165 — Enteral Transition Adaptor (October 21, 2022)
  • K162254 — Cedic Enteral ENFit Transition Connectors (May 4, 2017)
  • K151237 — Nutrisafe 2- ENFit Adaptor (February 9, 2016)
  • K151628 — Medline ENFit Connectors (July 24, 2015)
  • K150034 — AMT Enteral Transition Adapters (June 9, 2015)
  • K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (April 2, 2015)