510(k) · Neurology

FLASH EVD System (10-0002)

by 7D Surgical ULC

FLASH EVD System (10-0002) is an AI-enabled medical device from 7D Surgical ULC that the U.S. FDA cleared through 510(k) K242480 on December 27, 2024. Its lead review panel is Neurology and its primary product code is HAW (Neurological Stereotaxic Instrument).

See also FDA-cleared AI neurology devices in 2024, all FDA AI clearances in 2024, top neurology AI devices.

Key facts

Submission numberK242480
Pathway510(k)
Date of final decision
Company (FDA list)7D Surgical ULC
Lead review panelNeurology
Primary product codeHAW — Neurological Stereotaxic Instrument
Applicant (openFDA)7D Surgical ULC
Applicant locationToronto, CA
Device classClass 2
Regulation number21 CFR 882.4560
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. FLASH EVD System (10-0002) went through this pathway (K242480).

openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.

Product code HAW covers 8 devices on the FDA AI list. By decision date, this device is #6 of 8 under that code. 7D Surgical ULC has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code HAW)