Product code

NWW: Hysteroscope accessories

FDA product code · Class I · Obstetrics/Gynecology

Key facts

Product code NWW
Device Hysteroscope accessories
Device class Class I
Regulation number 884.1690
Review panel Obstetrics/Gynecology
Medical specialty Obstetrics/Gynecology
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than…

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 100–999 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

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

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