Product Classification

• Device: accessories, germicide, cleaning, for endoscopes
• Regulation Description: Endoscope and accessories.
• Definition: High level disinfection of reusable, heat-sensitive devices 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).
• Physical State: High level disinfection of reusable, heat-sensitive devices
• Technical Method: High level disinfection of reusable, heat-sensitive devices
• Target Area: High level disinfection of reusable, heat-sensitive devices
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General Hospital
• Product Code: NZA
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• 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

Third Party Review

Not Third Party Eligible