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U.S. Department of Health and Human Services

Product Classification

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Device laparoscope, general & plastic surgery
Regulation Description Endoscope and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeGCJ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices
Third Party Review
Accredited Persons

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