PRIMAPORE I.V.— 510(k) K893900
Substantially Equivalent for Some IndicationsSmith & Nephew United, Inc.
FDA 510(k) clearance K893900 for PRIMAPORE I.V., Substantially Equivalent for Some Indications on 1989-08-03. Applicant: Smith & Nephew United, Inc..
Clearance details
- Applicant
- Smith & Nephew United, Inc.
- Product code
- Code KGX
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Largo, FL, US
Adverse events under product code KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.