# Zap Surgical Systems, Inc.

- Location (FDA's records): San Carlos, CA
- FDA decisions: 4 (2017–2025): 4 510(k) clearances
- Names in FDA's records: Zap Surgical Systems, Inc. (2); Zap Surgical Systems (2)
- Product codes: IYE (4)
- 510(k) review time since 2016: median 76 days, against 90 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Accuray Incorporated: 1 (https://510kreport.com/company/accuray)

## Its most-cited devices
- K211663: Zap-X Radiosurgical System (2021), cited by 1
- K183698: Zap-X Radiosurgery System (2019), cited by 1
- K171804: Zap-X Radiosurgery System (2017), cited by 1

## Recent decisions
- K250392: ZAP-X Radiosurgery System (ZAP-X) (Nov 3, 2025)
- K211663: Zap-X Radiosurgical System (Jul 29, 2021)
- K183698: Zap-X Radiosurgery System (Feb 25, 2019)
- K171804: Zap-X Radiosurgery System (Sep 21, 2017)

Source page: https://510kreport.com/company/zap-surgical-systems