Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zap Surgical Systems with 4 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Nov 3, 2025: ZAP-X Radiosurgery System (ZAP-X).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 3, 2025 | ZAP-X Radiosurgery System (ZAP-X)K250392 · IYE | 510(k) clearances |
| Jul 25, 2025 | ZAP-X Radiosurgery System, Model: 300150Class II · If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a | Device recalls |
| Jul 5, 2022 | ZAP-X Radiosurgery SystemClass II · Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational | Device recalls |
| Jul 29, 2021 | Zap-X Radiosurgical SystemK211663 · IYE | 510(k) clearances |
| Feb 25, 2019 | Zap-X Radiosurgery SystemK183698 · IYE | 510(k) clearances |
| Sep 21, 2017 | Zap-X Radiosurgery SystemK171804 · IYE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
