# K242480: FLASH EVD System (10-0002)

- Pathway: 510(k) (Traditional)
- Applicant: 7D Surgical ULC
- Decided: Dec 27, 2024 after 128 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: 5 generations back to K993239 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, 7D Surgical, Inc. (2019) Summary page 5.

## Indications for use
FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

Source page: https://510kreport.com/device/K242480
Methodology: https://510kreport.com/methodology