SPiN Access Catheter, 180 Degrees for Use With Pentax Scopes
Catalogue number INS-5925, listed by Veran Medical Technologies, Inc., United States, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Veran Medical Technologies, Inc., United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K170023 |
| Record published | 2021-02-17 |
| Record revised | 2024-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
| Distribution end date | 2023-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INS-5925 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170023 | 2017-05-15 |
| K122106 | 2012-12-21 |
| K093995 | 2010-01-27 |
| K091934 | 2009-12-02 |
| K093146 | 2009-11-30 |
| K060903 | 2006-05-11 |
Recalls Naming This Product
15 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 |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 226 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 6484 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 9961 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 6318 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 522 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-08-10 | Class II | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to dem | 60102 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 1816.2 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 254.4 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 3692.2 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 526.4 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 1158 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 759.8 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 1908.2 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-15 | Class II | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay | 144 units |
| Olympus Corporation of the Americas | 510(k) number | 2022-12-13 | Class II | Under Investigation by firm | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional | 13 units |
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.