POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB— 510(k) K031097
Substantially EquivalentSophysa SA
FDA 510(k) clearance K031097 for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB, Substantially Equivalent on 2004-02-26. 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
- Wellesley, MA, US
Recent devices under product code JXG
view allMore clearances from Sophysa SA
view all- K162108 — Pressio 2 ICP Monitoring System
- K141227 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
- 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
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.