P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR— 510(k) K831678
Substantially EquivalentPudenz-Schulte Medical Research Corp.
FDA 510(k) clearance K831678 for P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR, Substantially Equivalent on 1983-06-24. Applicant: Pudenz-Schulte Medical Research Corp..
Clearance details
- Applicant
- Pudenz-Schulte Medical Research Corp.
- Product code
- Code JXG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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.