Product Classification

• Device: piston syringe lever
• Regulation Description: Piston syringe.
• Definition: Controlled compression of a piston syringe
• Physical State: Syringe holder with proximal advancement mechanism which places pressure through means of a screw lever and manual proximal screw-down control wheel
• Technical Method: Precision compression to proximal end of a syringe through means of a lever.
• Target Area: Urology
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: QBL
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5860
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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