IEC MEDSIGHT AND MEDBRIGHT— 510(k) K080809
Substantially EquivalentInnovative Endoscopy Components, LLC
FDA 510(k) clearance K080809 for IEC MEDSIGHT AND MEDBRIGHT, Substantially Equivalent on 2008-08-11. Applicant: Innovative Endoscopy Components, LLC.
Clearance details
- Applicant
- Innovative Endoscopy Components, LLC
- Product code
- Code FET
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ft. Lauderdale, FL, US
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.