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Zap Surgical Systems

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2639-2025Class IIZAP-X Radiosurgery System, Model: 300150July 25, 2025
Z-1742-2022Class IIZAP-X Radiosurgery SystemJuly 5, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K250392ZAP-X Radiosurgery System (ZAP-X)November 3, 2025
K211663Zap-X Radiosurgical SystemJuly 29, 2021
K183698Zap-X Radiosurgery SystemFebruary 25, 2019
K171804Zap-X Radiosurgery SystemSeptember 21, 2017