POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX— 510(k) K141227
Substantially EquivalentSophysa SA
FDA 510(k) clearance K141227 for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX, Substantially Equivalent on 2015-04-02. Applicant: Sophysa SA. Device class: 2.
Clearance details
- Applicant
- Sophysa SA
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mission Viejo, CA, US
Recent devices under product code JXG
view allMore clearances from Sophysa SA
view all- K162108 — Pressio 2 ICP Monitoring System
- K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
- K090342 — POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
- K062584 — PRESSIO ICP MONITORING SYSTEM
- K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.