RF Cannula— 510(k) K241367
Substantially EquivalentShanghai Samedical & Plastic Instruments Co., Ltd.
FDA 510(k) clearance K241367 for RF Cannula, Substantially Equivalent on 2025-01-23. Applicant: Shanghai Samedical & Plastic Instruments Co., Ltd..
Clearance details
- Applicant
- Shanghai Samedical & Plastic Instruments Co., Ltd.
- Product code
- Code GXI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.