Resascope RS-01/B— 510(k) K201113
Substantially EquivalentAdvanced Medical Systems Group Srl
FDA 510(k) clearance K201113 for Resascope RS-01/B, Substantially Equivalent on 2020-12-21. Applicant: Advanced Medical Systems Group Srl.
Clearance details
- Applicant
- Advanced Medical Systems Group Srl
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Pietro Viminario, IT
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.