Product Classification

• Device: system, surgical, computer controlled instrument
• Regulation Description: Endoscope and accessories.
• Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• Product Code: NAY
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling

Guidance Document

• Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible