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510(k) K896734

FEEDING TUBE by Unoplast A/S — Product Code FPD

K896734 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on December 21, 1990. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Unoplast A/S has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1990
Date Received
November 30, 1989
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 Unoplast A/S

  • K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER (November 5, 1990)
  • K896732 — UNOMETER 500 (November 2, 1990)
  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K896730 — SUCTION CATHETER STRAIGHT/COUDE (March 30, 1990)
  • K896733 — VACCON (February 1, 1990)
  • K802248 — DISARP ORIGINAL (September 26, 1980)

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