NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER— 510(k) K100520
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K100520 for NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER, Substantially Equivalent on 2010-03-17. Applicant: Nipro Medical Corporation.
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Code FIE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami, FL, US
Adverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
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.