Product Classification

• Device: pneumoperitoneum needle
• Regulation Description: Endoscope and accessories.
• Definition: For establishment of a pneumoperitoneum in abdomen.
• Physical State: May include: needle, stylet, housing handle.
• Technical Method: Instrument inserted into abdomen and gasses or fluids are passed into needle to inflate the abdominal cavity.
• Target Area: abdominal cavity
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FHO
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); 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