# K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

- Pathway: 510(k) (Special)
- Applicant: 7D Surgical, Inc.
- Decided: Nov 27, 2019 after 40 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K993239 (2000). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181041: 7D Surgical System Cranial Application, 7D Surgical, Inc. (2018) Summary page 4.

## Most influential descendants
- K230661: Zeta Cranial Navigation System (2023), 3 descendants of its own
- K233903: Zeta Cranial Navigation System (ZNS131-US) (2024), 2 descendants of its own
- K242351: Zeta Cranial Navigation System (ZNS131-US) (2024), 1 descendant of its own
- K253663: Zeta Navigation System (2026), 0 descendants of its own
- K242480: FLASH EVD System (10-0002) (2024), 0 descendants of its own

## Indications for use
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K192945
Methodology: https://510kreport.com/methodology