LUMILOC (TM) SAFETY INTRODUCER NEEDLE— 510(k) K070449
Substantially EquivalentSpecialized Health Products International, Inc.
FDA 510(k) clearance K070449 for LUMILOC (TM) SAFETY INTRODUCER NEEDLE, Substantially Equivalent on 2007-06-14. Applicant: Specialized Health Products International, Inc..
Clearance details
- Applicant
- Specialized Health Products International, Inc.
- Product code
- Code KNT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake, UT, US
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.