Cleared Traditional

K242575 - Stereotaxic Guiding Surgical Devices

K242575 is an FDA 510(k) clearance for Stereotaxic Guiding Surgical Devices, manufactured by Brain Navi Biotechnology Co., Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K242575 · Brain Navi Biotechnology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
267d
Days
Class 2
Risk

K242575 is an FDA 510(k) clearance for the Stereotaxic Guiding Surgical Devices, NaoTrac S. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brain Navi Biotechnology Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on May 23, 2025 after a review of 267 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 Brain Navi Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K242575

510(k) Number K242575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2024
Decision Date May 23, 2025
Days to Decision 267 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
119d slower than avg
Panel avg: 148d · This submission: 267d
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 Consultant

Elite Biomedical Consulting, Inc.
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 258
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