Visualase
Stylet 9735566 1MM Visualization
3manufacturers in China registered for this device type
5catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shenzhen Xinzhengyu Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | GAH |
| Device type | Stylet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-04 |
| Record revised | 2025-10-09 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-10-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9735566 | In distribution | |
| 9735571 | In distribution | |
| 9735566 | Withdrawn | |
| 9735566 | Withdrawn | |
| 9735566 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lion | Hans Biomed Corp. | 17 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 9 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 7 |
| Summa Orthopaedics System Surgical Instrument | Jeil Medical Corporation | 6 |
| Surgical Instrument | Jeil Medical Corporation | 6 |
| OrthoPediatrics Cannulated Screw System | Orthopediatrics, Corp | 6 |
| Osseoflex® | Merit Medical Systems, Inc. | 6 |
| Inlet System Surgical Instrument | Jeil Medical Corporation | 5 |
| Disc Preparation Instruments | Highridge Medical, LLC | 5 |
| Symmetry Frazier | Aspen Surgical Products, Inc. | 5 |
| Prometheus System Surgical Instrument | Jeil Medical Corporation | 5 |
| Breckenridge Acdf System | Highridge Medical, LLC | 5 |
Showing 12 of 50. All products under Stylet, Surgical, General & Plastic Surgery
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-09-01 | Class II | Mixed-up of materials/components | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging sys | 100 total units | 2017-03-27 |
| 2016-09-01 | Class II | Mixed-up of materials/components | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging sys | 100 total units | 2017-03-27 |
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.