Signal Catheter— 510(k) K182635
Substantially EquivalentSafe Medical Design
FDA 510(k) clearance K182635 for Signal Catheter, Substantially Equivalent on 2019-01-10. Applicant: Safe Medical Design. Device class: 2.
Clearance details
- Applicant
- Safe Medical Design
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code EZL
view allAdverse 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.