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510(k) K162254

Cedic Enteral ENFit Transition Connectors by Cedic S.R.L. — Product Code PIO

K162254 is an FDA 510(k) premarket notification submitted by Cedic S.R.L. for the device "Cedic Enteral ENFit Transition Connectors". The FDA issued a decision of Substantially Equivalent on May 4, 2017. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Cedic S.R.L. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2017
Date Received
August 10, 2016
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)
  • K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (April 2, 2015)
  • K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT (October 17, 2014)
  • 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)
  • 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)
  • K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT (October 17, 2014)

FDA data resources