Cleared Traditional

K253856 - Geniant Cranial (Navigated Neurosurgical Positioning Robot)

K253856 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 281-day FDA review.

K253856 · KOH YOUNG TECHNOLOGY, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
281d
Days
Class 2
Risk

K253856 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. (Yeoju, KR). The FDA issued a Cleared decision on September 10, 2026 after a review of 281 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 - K253856

510(k) Number K253856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2025
Decision Date September 10, 2026
Days to Decision 281 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
132d slower than avg
Panel avg: 149d · This submission: 281d
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 384
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