Stereotaxic Guiding Surgical Devices, NaoTrac S

Q: What is the product code of K242575?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K242575 · Brain Navi Biotechnology Co., Ltd.

Substantially Equivalent

510(k) numberK242575

Submission

Device name: Stereotaxic Guiding Surgical Devices, NaoTrac S
Applicant: Brain Navi Biotechnology Co., Ltd.
Hsinchu County, TW
Received: August 29, 2024
Decision date: May 23, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HAW – Neurological Stereotaxic Instrument
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

Other 510(k)s with product code HAW

510(k)	Device	Applicant	Decision
K253856	Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional	Koh Young Technology, Inc.	09/10/2026SE
K261932	Leksell® Vantage Stereotactic SystemHAW · Traditional	Elekta Solutions AB	08/05/2026SE
K253663	Zeta Navigation SystemHAW · Traditional	Zeta Surgical, Inc.	05/01/2026SE
K253379	Stealth AXiS Cranial clinical applicationHAW · Traditional	Medtronic Navigation, Inc.	03/26/2026SE
K231897	NeuroAlign softwareHAW · Traditional	Medivis, Inc.	10/21/2025SE
K251317	SOLOPASS 2.0 SystemHAW · Traditional	Intravent Medical Partners	09/05/2025SE
K250893	Ball Joint Guide Array (66295)HAW · Traditional	Bayer Medical Care, Inc.	09/04/2025SE
K250505	Ez-FiducialsHAW · Traditional	Phasor Health, LLC	07/09/2025SE
K241327	Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional	Claronav	02/05/2025SE
K243698	Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional	Brainlab AG	01/28/2025SE

Questions and answers

When was Stereotaxic Guiding Surgical Devices, NaoTrac S cleared by the FDA?

Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) received a 510(k) decision of Substantially Equivalent on May 23, 2025, 267 days after the submission was received.

What is the product code of K242575?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.