PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS— 510(k) K061009
Substantially EquivalentOnset Medical Corporation
FDA 510(k) clearance K061009 for PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS, Substantially Equivalent on 2006-05-02. Applicant: Onset Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Onset Medical Corporation
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mission Viejo, CA, US
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More clearances from Onset Medical Corporation
view allAdverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
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.