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510(k) K220165

Enteral Transition Adaptor by GBUK Group, Ltd. — Product Code PIO

K220165 is an FDA 510(k) premarket notification submitted by GBUK Group, Ltd. for the device "Enteral Transition Adaptor". The FDA issued a decision of Substantially Equivalent on October 21, 2022. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. GBUK Group, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2022
Date Received
January 20, 2022
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 GBUK Group, Ltd.

  • K203633 — Enteral Extension Sets (August 19, 2021)

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)
  • 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)
  • K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT (October 17, 2014)

FDA data resources