SHV — Reusable Intermittent Urinary Catheter System Class II

FDA Device Classification

Classification Details

Product Code
SHV
Device Class
Class II
Regulation Number
876.5120
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

A reusable intermittent urinary catheter system consists of a reusable intermittent urinary catheter inserted through the urethra into the bladder for urine drainage and the components necessary to reprocess the intermittent catheter. The reusable intermittent urinary catheter can be reused after reprocessing (e.g., cleaning and disinfection) with the components necessary to reprocess the intermittent catheter. The system may include cleaning and microbicidal agents, lubricant and disposable components. The reusable intermittent catheter and any reusable reprocessing components are intended for single patient reuse.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN250023cathbuddyAurie SystemApril 30, 2026