K243591
Substantially EquivalentOPTOVISION Endoscopic Light Source Unit
- Applicant
- Optosurgical, LLC
- Product code
- OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.