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510(k) K121105

NUTRISAFE 2 FEEDING TUBE by Vygon Corp. — Product Code FPD

K121105 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "NUTRISAFE 2 FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on December 18, 2012. 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
December 18, 2012
Date Received
April 12, 2012
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)
  • 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 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)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • 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