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FDA 510(k)

ZAP-X Radiosurgery System (ZAP-X)

K-Number: K250392 · 2025-11-03

ApplicantZap Surgical Systems, Inc.
Decision Date2025-11-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZAP-X Radiosurgery System (ZAP-X) is a medical device manufactured by Zap Surgical Systems, Inc.. It received FDA 510(k) clearance on 2025-11-03 under approval number K250392. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAP-X Radiosurgery System (ZAP-X)?

ZAP-X Radiosurgery System (ZAP-X) is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Zap Surgical Systems, Inc.. The 510(k) number is K250392.

When was ZAP-X Radiosurgery System (ZAP-X) approved by the FDA?

ZAP-X Radiosurgery System (ZAP-X) received FDA 510(k) clearance on 2025-11-03, under approval number K250392.

What company makes ZAP-X Radiosurgery System (ZAP-X)?

ZAP-X Radiosurgery System (ZAP-X) is manufactured by Zap Surgical Systems, Inc..

What is the FDA product code for ZAP-X Radiosurgery System (ZAP-X)?

The FDA product code for ZAP-X Radiosurgery System (ZAP-X) is IYE.

Related Clinical Trials

NCT04988750 Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients COMPLETED

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Zap Surgical Systems, Inc.

K211663Zap-X Radiosurgical System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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