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510(k) K905677

JEJUNO-CATH KIT by Health Improvement Assoc. — Product Code FPD

K905677 is an FDA 510(k) premarket notification submitted by Health Improvement Assoc. for the device "JEJUNO-CATH KIT". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Health Improvement Assoc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
December 19, 1990
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 Health Improvement Assoc.

  • K921478 — GUARDPORT (January 11, 1995)
  • K875232 — INTRO-REDUCER (NASOGASTRIC TUBE) (June 2, 1988)
  • K770086 — SANAR (April 18, 1977)

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