Product Classification

• Device: rectal insert
• Regulation Description: Gastrointestinal tube and accessories.
• Definition: Acts as a barrier to the passage of fecal matter through the rectum.
• Physical State: Comprised of a silicone Insert and a plastic fingertip applicator. The Insert has a barbell shape, the end which sits inside of the rectum ranges in size from 22 mm to 28 mm in width. The Insert is 35 mm long and the external flare is 24 mm.
• Technical Method: Designed for self-insertion to seal and prevent the involuntary leakage of stool from the rectum.
• Target Area: To be placed across the anal sphincter.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: PBP
• 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: 876.5980
• 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

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc