Cleared Traditional

K241333 - Geniant Cranial (Navigated Neurosurgica...

K241333 is an FDA 510(k) clearance for Geniant Cranial (Navigated Neurosurgica..., manufactured by KOH YOUNG TECHNOLOGY, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K241333 · KOH YOUNG TECHNOLOGY, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
252d
Days
Class 2
Risk

K241333 is an FDA 510(k) clearance for the Geniant Cranial (Navigated Neurosurgical Positioning Robot). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by KOH YOUNG TECHNOLOGY, Inc. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on January 17, 2025 after a review of 252 days - an extended review cycle.

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 KOH YOUNG TECHNOLOGY, Inc. devices

FDA 510(k) Submission Details - K241333

510(k) Number K241333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date January 17, 2025
Days to Decision 252 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
104d slower than avg
Panel avg: 148d · This submission: 252d
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 261
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K241333.
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · Claronav · Feb 2025
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
FLASH EVD System (10-0002)
K242480 · 7D Surgical ULC · Dec 2024
Zeta Cranial Navigation System (ZNS131-US)
K242351 · Zeta Surgical, Inc. · Oct 2024
Bone Anchor (NGS-BA-01)
K233703 · ClearPoint Neuro, Inc. · Apr 2024