Product Classification

• Device: anti fog solution and accessories, endoscopy
• Regulation Description: Endoscope and accessories.
• Definition: To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
• Physical State: anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution
• Technical Method: Apply solution to lens, typically by spraying or wiping.
• Target Area: endoscopic lens
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: OCT
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc