EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)— 510(k) K252341
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K252341 for EVIS EXERA III BRONCHOVIDEOSCOPE (3 models), Substantially Equivalent on 2026-04-23. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Device name as filed
- EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.