Product code SHV— Gastroenterology, Urology
Aurie System
- Classification name
- Reusable Intermittent Urinary Catheter System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5120
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SHV
FDA has cleared device under product code SHV, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SHV
Recent clearances under product code SHV
Data sourced from openFDA. This site is unofficial and independent of the FDA.