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510(k) K981629

NUTRISAFE ENTERAL FEEDING TUBE by Schiff & Co. — Product Code FPD

K981629 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "NUTRISAFE ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on February 4, 1999. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Schiff & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1999
Date Received
May 7, 1998
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 Schiff & Co.

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K982136 — JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (March 24, 1999)
  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K974141 — PLUS REUSABLE RESUSCITATOR (May 21, 1998)
  • K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (October 28, 1996)
  • K955085 — HM-CAP EIA TEST (MODIFICATION) (February 9, 1996)
  • K944159 — HM-CAP EIA KIT (July 18, 1995)
  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)
  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 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