510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN250023Unknown

Aurie System

Cathbuddy, Inc., Syracuse NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN250023 is the FDA 510(k) clearance record for Aurie System, a class II device, cleared for Cathbuddy, Inc. on under FDA product code SHV (Reusable Intermittent Urinary Catheter System). FDA's definition for product code SHV 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...". FDA records list one 510(k) clearance for Cathbuddy, Inc. As of , FDA records show no recalls naming DEN250023.

Clearance record

Decision date
Received
(328 days to decision)
Product code
SHV Reusable Intermittent Urinary Catheter System
Regulation
21 CFR 876.5120
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cathbuddy, Inc. 841 E. Fayette St., Syracuse NY
Third party review
No

Clearances, product code SHV

Trailing 12 months
1 clearance under product code SHV in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260