RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set— 510(k) K160077
Substantially EquivalentJbw7 Innovations, LLC
FDA 510(k) clearance K160077 for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set, Substantially Equivalent on 2016-07-12. Applicant: Jbw7 Innovations, LLC.
Clearance details
- Applicant
- Jbw7 Innovations, LLC
- Product code
- Code LJE
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southfield, MI, US
Adverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
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.