FDA product code SHV: Reusable Intermittent Urinary Catheter System

SHV is the FDA product code for reusable intermittent urinary catheter system. It is a Class II device, regulated under 21 CFR 876.5120 and reviewed by the Gastroenterology and Urology panel. Devices under SHV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SHV devices

openFDA lists no recalls for product code SHV.

Frequently asked questions

What is FDA product code SHV?

SHV is the FDA product code for reusable intermittent urinary catheter system. It is a Class II device, regulated under 21 CFR 876.5120 and reviewed by the Gastroenterology and Urology panel.

What device class is SHV?

Class II, regulation 21 CFR 876.5120. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SHV
• Run a recall and safety report across every SHV manufacturer
• Watch product code SHV for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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