Product code

EQJ: Bur, ear, nose and throat

FDA product code · Class I · Ear Nose & Throat

Key facts

Product code EQJ
Device Bur, ear, nose and throat
Device class Class I
Regulation number 874.4140
Review panel Ear Nose & Throat
Medical specialty Ear Nose & Throat
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • 10–99 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 1,000+ UDI devices (GUDID)
  • 1,000+ MAUDE adverse event reports
  • 1–9 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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