Product code

NWV: Laparoscopic accessories, gynecologic

FDA product code · Class I · Obstetrics/Gynecology

Key facts

Product code NWV
Device Laparoscopic accessories, gynecologic
Device class Class I
Regulation number 884.1720
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 laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female…

At a glance

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