Zap Surgical Systems

Medical device manufacturer in San Carlos, CA.

4510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K250392ZAP-X Radiosurgery System (ZAP-X)IYE · Traditional 11/03/2025SE
K211663Zap-X Radiosurgical SystemIYE · Traditional 07/29/2021SE
K183698Zap-X Radiosurgery SystemIYE · Traditional 02/25/2019SE
K171804Zap-X Radiosurgery SystemIYE · Traditional 09/21/2017SE

Recalls

RecallProductInitiated
Z-2639-2025 Class IIZAP-X Radiosurgery System, Model: 300150If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180… 07/25/2025Open, Classified
Z-1742-2022 Class IIZAP-X Radiosurgery SystemSoftware issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5… 07/05/2022Open, Classified