Cleared Traditional

K242480 - FLASH EVD System (10-0002)

K242480 is an FDA 510(k) clearance for FLASH EVD System (10-0002), manufactured by 7D Surgical ULC. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K242480 · 7D Surgical ULC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
128d
Days
Class 2
Risk

K242480 is an FDA 510(k) clearance for the FLASH EVD System (10-0002). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by 7D Surgical ULC (Toronto, CA). The FDA issued a Cleared decision on December 27, 2024 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all 7D Surgical ULC devices

FDA 510(k) Submission Details - K242480

510(k) Number K242480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2024
Decision Date December 27, 2024
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 242
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K242480.
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · Brainlab AG · Jan 2025
ClearPoint System (Software Version 3.0)
K243657 · ClearPoint Neuro, Inc. · Jan 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · KOH YOUNG TECHNOLOGY, Inc. · Jan 2025
Zeta Cranial Navigation System (ZNS131-US)
K242351 · Zeta Surgical, Inc. · Oct 2024
Bone Anchor (NGS-BA-01)
K233703 · ClearPoint Neuro, Inc. · Apr 2024
SmartFrame OR
K233141 · ClearPoint Neuro, Inc. · Jan 2024