Product Classification

• Device: endoscopic grasping/cutting instrument, non-powered
• Regulation Description: Endoscope and accessories.
• Definition: To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
• Physical State: Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger
• Technical Method: Place through an endoscope to reach desired area.
• Target Area: various tissues, stones or other foreign bodies within GI and GU tract.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: OCZ
• 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