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510(k) K151237

Nutrisafe 2- ENFit Adaptor by Vygon — Product Code PIO

K151237 is an FDA 510(k) premarket notification submitted by Vygon for the device "Nutrisafe 2- ENFit Adaptor". The FDA issued a decision of Substantially Equivalent on February 9, 2016. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Vygon has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2016
Date Received
May 11, 2015
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 Vygon

  • K141026 — LEADERFLEX (July 30, 2014)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K073493 — HEPATOSTAT SET (May 6, 2008)
  • K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 (November 30, 2007)
  • K061796 — HEPATOSTAT SET, MODEL 760X (November 2, 2006)
  • K061250 — MULTICATH EXPERT (September 29, 2006)
  • K062425 — LIFECATH S PICC AND MIDLINE CATHETER (September 15, 2006)
  • K060944 — NUTRISAFE 2 (September 15, 2006)
  • K052564 — VYGON LEADER-FLEX (April 5, 2006)

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)
  • 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