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510(k) K100099

ORAL/ENTERAL SYRINGES by Philips Children'S Medical Ventures — Product Code FPD

K100099 is an FDA 510(k) premarket notification submitted by Philips Children'S Medical Ventures for the device "ORAL/ENTERAL SYRINGES". The FDA issued a decision of Substantially Equivalent on June 14, 2010. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)

FDA data resources