Sophysa
TEMPERATURE PATIENT MONITOR CABLE / HELLIGE, DATEX-OHMEDA, NIHON KOHDEN, MINDRAY & DATASCOPE- JACK 6,35 mm
5manufacturers in China registered for this device type
32catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Sophysa, France |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| Establishment | Manufacturer |
| 510(k) | K062584 |
| Record published | 2017-07-25 |
| Record revised | 2023-05-18 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSO-4000 | In distribution | |
| PSO-MCT-A | In distribution | |
| PSO-MC01 | In distribution | |
| PSO-MCT-F | In distribution | |
| PSO-VT | In distribution | |
| PSO-PT | In distribution | |
| PSO-MCT-B | In distribution | |
| PSO-MC04 | In distribution | |
| PSO-MC05 | In distribution | |
| PSO-VTT | In distribution | |
| PSO-MC02 | In distribution | |
| PSO-PTT | In distribution | |
| PSO-PB | In distribution | |
| PSO-VTT | In distribution | |
| PSO-MCT-C | In distribution | |
| PSO-MRI | In distribution | |
| PSO-PBT | In distribution | |
| PSO-VT | In distribution | |
| PSO-MCT-E | In distribution | |
| PSO-MC08 | In distribution | |
| PSO-MC03 | In distribution | |
| PSO-EC30 | In distribution | |
| PSO-EC20 | In distribution | |
| PSO-VTT | In distribution | |
| PSO-MC06 | Withdrawn | |
| PSO-IN00 | Withdrawn | |
| PSO-PTT | Withdrawn | |
| PSO-MC10 | Withdrawn | |
| PSO-3000 | Withdrawn | |
| PSO-PBT | Withdrawn | |
| PSO-TX00 | Withdrawn | |
| PSO-MC07 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Braincare | Braincare Desenvolvimento E Inovacao Tecnologica SA | 24 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Codman® | Integra LifeSciences Production Corporation | 19 |
| Integra® | Integra Lifesciences (Ireland) Limited | 17 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Natus | Natus Medical Incorporated | 15 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252241 | 2026-04-10 |
| K162108 | 2017-04-17 |
| K062584 | 2007-07-05 |
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 |
|---|---|---|---|---|---|---|
| Sophysa | 510(k) number | 2025-11-17 | Class II | Software design | Customer complaints of Pressio monitor rebooting. | 105 units |
| Sophysa | 510(k) number | 2024-04-09 | Class II | Process change control | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leak | 3487 units OUS |
| Sophysa | 510(k) number | 2024-04-09 | Class II | Process change control | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leak | 3175 units- 41 units US; 3134 units OUS |
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.