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510(k) K100163

NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX by Vygon Corp. — Product Code FPD

K100163 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX". The FDA issued a decision of Substantially Equivalent on October 13, 2011. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Vygon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2011
Date Received
January 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Vygon Corp.

  • K151237 — Nutrisafe 2- ENFit Adaptor (February 9, 2016)
  • K141026 — LEADERFLEX (July 30, 2014)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • 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 FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)

FDA data resources