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510(k) K100526

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE by Kentec Medical, Inc. — Product Code FPD

K100526 is an FDA 510(k) premarket notification submitted by Kentec Medical, Inc. for the device "AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on April 22, 2010. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Kentec Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2010
Date Received
February 24, 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 Kentec Medical, Inc.

  • K120272 — AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (February 17, 2012)
  • K050443 — ACCU-LEAD (September 2, 2005)
  • K970686 — ACCUTEMP-PROBE (August 25, 1997)
  • K960080 — ACCUTEMP PROBE (May 1, 1996)
  • K853475 — GRAM-MA NEONATAL SC (September 5, 1985)

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)
  • 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)

FDA data resources