Zap Surgical Systems Inc.
San Carlos, CA, US
ZAP SURGICAL SYSTEMS INC. appears in FDA device records in San Carlos, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Zap Surgical Systems Inc. between 2017 and 2025. The busiest year on record is 2017, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | IYE | Substantially Equivalent | |
| K211663 | Zap-X Radiosurgical System | IYE | Substantially Equivalent | |
| K183698 | Zap-X Radiosurgery System | IYE | Substantially Equivalent | |
| K171804 | Zap-X Radiosurgery System | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012039133 | 3012039133 | ZAP SURGICAL SYSTEMS INC. | 590 Taylor Way, San Carlos, CA 94070 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2639-2025 | ZAP-X Radiosurgery System, Model: 300150 | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. | Class II | Open, Classified | |
| Z-1742-2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain