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510(k) K892431

KENDALL CURITY FEEDING TUBES by The Kendal Co. — Product Code FPD

K892431 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL CURITY FEEDING TUBES". The FDA issued a decision of Substantially Equivalent on May 19, 1989. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1989
Date Received
April 10, 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 The Kendal Co.

  • K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (March 17, 2000)
  • K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY C (September 28, 1999)
  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K942774 — POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (July 20, 1994)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)

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