510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SHVClass II

Reusable Intermittent Urinary Catheter System

21 CFR 876.5120 / Gastroenterology, Urology
FDA source (opens on fda.gov)

SHV is the FDA product code for Reusable Intermittent Urinary Catheter System, a class II device type, regulated under 21 CFR 876.5120. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHV
Device name
Reusable Intermittent Urinary Catheter System
FDA 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.
Regulation
21 CFR 876.5120
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SHV

By decision year
1 clearance under product code SHV with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHV by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHV
Applicants holding the most 510(k) clearances under product code SHV
ApplicantClearances
Cathbuddy, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SHV.