Leksell Stereotactic System
CROSS HAIR TARGET, STAINLESS - ingoing part CROSS HAIR TARGET CROSS
5manufacturers in China registered for this device type
93catalogue numbers in this listing
1510(k) clearance
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.
| 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
| Listed by | Elekta Solutions AB, Sweden |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K152558 |
| Record published | 2025-09-17 |
| Record revised | 2025-09-15 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 20 to 110 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1040381 | In distribution | ||
| 1040336 | Length 27.5 mm | In distribution | |
| 1040335 | Length 25.0 mm | In distribution | |
| 1040483 | In distribution | ||
| 1040320 | In distribution | ||
| 1040303 | In distribution | ||
| 1040309 | In distribution | ||
| 1040433 | In distribution | ||
| 1040224 | In distribution | ||
| 1040432 | In distribution | ||
| 1040434 | In distribution | ||
| 1040337 | Length 30 mm | In distribution | |
| 1040318 | In distribution | ||
| 1040476 | In distribution | ||
| 1040328 | In distribution | ||
| 1040326 | In distribution | ||
| 1040341 | Length 40.0 mm | In distribution | |
| 1040485 | In distribution | ||
| 1040352 | Length 110 mm | In distribution | |
| 1040321 | In distribution | ||
| 1040347 | Length 65.0 mm | In distribution | |
| 1040333 | Length 20.0 mm | In distribution | |
| 1040362 | In distribution | ||
| 1040385 | In distribution | ||
| 1040500 | In distribution | ||
| 1040349 | Length 75 mm | In distribution | |
| 1040474 | In distribution | ||
| 1040392 | In distribution | ||
| 1040379 | In distribution | ||
| 1040325 | In distribution | ||
| 1040223 | In distribution | ||
| 1040358 | In distribution | ||
| 1040368 | In distribution | ||
| 1040373 | In distribution | ||
| 1040342 | Length 42.5 mm | In distribution | |
| 1040340 | Length 37.5 mm | In distribution | |
| 1040170 | In distribution | ||
| 1040486 | In distribution | ||
| 1040351 | Length 90 mm | In distribution | |
| 1040498 | In distribution | ||
| 1040455 | In distribution | ||
| 1040458 | In distribution | ||
| 1040310 | In distribution | ||
| 1040316 | In distribution | ||
| 1040443 | In distribution | ||
| 1040372 | In distribution | ||
| 1040322 | In distribution | ||
| 1040327 | In distribution | ||
| 1040339 | Length 35 mm | In distribution | |
| 1040334 | Length 22.5 mm | In distribution | |
| 1040398 | In distribution | ||
| 1040442 | In distribution | ||
| 1040364 | In distribution | ||
| 1040344 | Length 50 mm | In distribution | |
| 1040179 | In distribution | ||
| 1040330 | In distribution | ||
| 1040356 | In distribution | ||
| 1040324 | In distribution | ||
| 1040445 | In distribution | ||
| 1040307 | In distribution | ||
| 1040302 | In distribution | ||
| 1040397 | In distribution | ||
| 1040312 | In distribution | ||
| 1040338 | Length 32.5 mm | In distribution | |
| 1040304 | In distribution | ||
| 1040350 | Length 80 mm | In distribution | |
| 1040475 | In distribution | ||
| 1040345 | Length 55 mm | In distribution | |
| 1040400 | In distribution | ||
| 1040393 | In distribution | ||
| 1040308 | In distribution | ||
| 1040388 | In distribution | ||
| 1040499 | In distribution | ||
| 1040387 | In distribution | ||
| 1040178 | In distribution | ||
| 1040343 | Length 45.0 mm | In distribution | |
| 1040153 | 4 | In distribution | |
| 1040484 | In distribution | ||
| 1040383 | In distribution | ||
| 1040490 | In distribution | ||
| 1040332 | In distribution | ||
| 1040497 | In distribution | ||
| 1040301 | In distribution | ||
| 1040375 | In distribution | ||
| 1040448 | In distribution | ||
| 1040311 | In distribution | ||
| 1040377 | In distribution | ||
| 1040431 | In distribution | ||
| 1040331 | In distribution | ||
| 1040360 | In distribution | ||
| 1040346 | Length 60 mm | In distribution | |
| 1040329 | In distribution | ||
| 1040348 | Length 70 mm | In distribution |
Same 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 |
| 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 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261932 | 2026-08-05 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Elekta Instrument AB | 510(k) number | 2024-09-25 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on th | 111 kits (666 needles) |
| Elekta Instrument AB | 510(k) number | 2024-03-15 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy ne | 601 needles |
| Elekta Instrument AB | 510(k) number | 2023-03-01 | Class II | Labeling Change Control | The incorrect IFU was distributed with the devices. | 70 devices |
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.