SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS— 510(k) K980092
Substantially Equivalent - Subject to Tracking Reg.Smith & Nephew, Inc.
FDA 510(k) clearance K980092 for SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS, Substantially Equivalent - Subject to Tracking Reg. on 1998-03-09. Applicant: Smith & Nephew, Inc..
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Andover, MA, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.