Product code

FOD: Device, occlusion, umbilical

FDA product code · Class I · General Hospital

Key facts

Product code FOD
Device Device, occlusion, umbilical
Device class Class I
Regulation number 880.5950
Review panel General Hospital
Medical specialty General Hospital
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 10–99 UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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