Cross Vascular RF Generator and Footswitch (optional accessory)— 510(k) K232809
Substantially EquivalentCross Vascular, Inc.
FDA 510(k) clearance K232809 for Cross Vascular RF Generator and Footswitch (optional accessory), Substantially Equivalent on 2023-10-12. Applicant: Cross Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cross Vascular, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solana Beach, CA, US
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More clearances from Cross Vascular, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.