Silicone Foley Catheter for single use— 510(k) K172807

Name: FDA 510(k) clearance K172807
Creator: U.S. Food and Drug Administration
Published: 2018-06-04

Substantially Equivalent

Changzhou Rongxin Medicine Minimal Invasion Technology

FDA 510(k) clearance K172807 for Silicone Foley Catheter for single use, Substantially Equivalent on 2018-06-04. Applicant: Changzhou Rongxin Medicine Minimal Invasion Technology. Device class: 2.

Clearance details

Applicant: Changzhou Rongxin Medicine Minimal Invasion Technology
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-18
Decision date: 2018-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jintan City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZL

view all

K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)2026-09-04
K262056 — Rusch Latex Gold Foley Catheter2026-08-05
K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20
K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)2025-06-16
K241424 — InnoCare Specialty Foley Catheter2024-09-18

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.