Cross Vascular RF Generator and Footswitch (optional accessory)— 510(k) K232809

Substantially Equivalent

Cross 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..

Clearance details

Applicant: Cross Vascular, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-09-12
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse 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, 2020-01-01 through 2026-04-23. 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.