NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE— 510(k) K071145
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K071145 for NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE, Substantially Equivalent on 2007-09-07. Applicant: Nipro Medical Corporation.
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Code MPB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Miami, FL, US
Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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.