Product code

FHY: Jelly, contact, for transurethral surgical instrument

FDA product code · Class II · Gastroenterology/Urology

Key facts

Product code FHY
Device Jelly, contact, for transurethral surgical instrument
Device class Class II
Regulation number 876.4300
Review panel Gastroenterology/Urology
Medical specialty Gastroenterology/Urology
Submission type 510(k)
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
  • None UDI devices (GUDID)
  • None 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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