Navigated Shunt Needle

Navigated Shunt Needle for use with Navient system, cranial

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HAW
Manufacturer City Province Registered as Device types
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Sinovation (Beijing) Medical Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for Navigated Shunt Needle
Listed by ClaroNav Kolahi Inc
FDA product code HAW
Device type Neurological Stereotaxic Instrument
Device class Class 2
Regulation 21 CFR 882.4560
510(k) K241327
Record published 2025-02-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Navigated Shunt Needle
Catalogue number Size Status
950-NC-NSN In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Neurological Stereotaxic Instrument Medtronic Navigation, Inc. 844
PMT Corporation – Stereotactic PMT Corp. 255
Leksell Stereotactic System Elekta Instrument AB 199
Neurological Stereotaxic Instrument Inomed Medizintechnik Gmbh 146
Neurological Stereotaxic Instrument Stryker Leibinger Gmbh & Co. KG 125
Geniant Cranial KOH Young Technology Inc. 113
CRW® Integra Lifesciences Corporation 107
Leksell Stereotactic System Elekta Solutions AB 93
microTargeting™ Insertion Tube with Stylet FHC, Inc. 60
Leksell Stereotactic System Neurosurgical Instruments Elekta Instrument AB 58
Leksell Vantage Stereotactic System Elekta Instrument AB 53
Stealth Autoguide™ System Medtronic Navigation, Inc. 50

Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer