EVIS EXERA III Bronchovideoscope Olympus BF-XT190— 510(k) K183419
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K183419 for EVIS EXERA III Bronchovideoscope Olympus BF-XT190, Substantially Equivalent on 2019-09-05. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- 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
- Hachioji-Shi, 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 →
Recalls naming K183419
K-number listed on FDA's recall record- Z-0193-2024 — EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
- Z-2498-2023 — Olympus Bronchovideoscope, Models BF-XT190.
- Z-2017-2023 — Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183419.
Data sourced from openFDA. This site is unofficial and independent of the FDA.