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U.S. Department of Health and Human Services

Product Classification

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Device laparoscope and accessories, gynecologic, reprocessed
Regulation Description Gynecologic laparoscope and accessories.
Definition 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 genital organs.This generic type of device may include: trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeNMH
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.1720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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