PeriView FLEX— 510(k) K181193
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K181193 for PeriView FLEX, Substantially Equivalent on 2018-07-03. Applicant: Olympus Surgical Technologies America.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code KTI
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Southborough, MA, US
Adverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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.