BRONCHOSCOPE BF-N20— 510(k) K910423
Substantially EquivalentOlympus Corp.
FDA 510(k) clearance K910423 for BRONCHOSCOPE BF-N20, Substantially Equivalent on 1991-04-29. Applicant: Olympus Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus 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
- Lake Success, NY, US
Recent devices under product code EOQ
view allMore clearances from Olympus Corp.
view allAdverse 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 K910423
K-number listed on FDA's recall record- Z-2502-2023 — Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Z-2564-2021 — BF-N20 OES Bronchofiberscope, Model No. BF-N20
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910423.
Data sourced from openFDA. This site is unofficial and independent of the FDA.