Silicone Foley Catheter for single use— 510(k) K172807
Substantially EquivalentChangzhou 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.
Clearance details
- Applicant
- Changzhou Rongxin Medicine Minimal Invasion Technology
- Product code
- Code EZL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jintan City, CN
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, through . 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.