SYSLOC MINI V3— 510(k) K110157
Substantially EquivalentJMS North America Corporation
FDA 510(k) clearance K110157 for SYSLOC MINI V3, Substantially Equivalent on 2011-02-11. Applicant: JMS North America Corporation.
Clearance details
- Applicant
- JMS North America Corporation
- Product code
- Code FIE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Crofton, MD, 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.