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PBP — Rectal Insert Class II

FDA Device Classification

Classification Details

Product Code
PBP
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Acts as a barrier to the passage of fecal matter through the rectum.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243367minnesota medical technologiesMinnesota Medical Technologies Fecal Incontinence Insert (My Miracle)July 22, 2025
K122003renew medicalRENEW INSERTOctober 26, 2012