Zap Surgical Systems

FDA Regulatory Profile

Zap Surgical Systems appears in FDA public data with 2 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2639-2025, Class II) was initiated on July 25, 2025. Its most recent 510(k) clearance was granted on November 3, 2025.

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