EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT— 510(k) K033225
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K033225 for EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT, Substantially Equivalent on 2003-10-16. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- 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
- Melville, NY, US
Recent devices under product code EOQ
view allMore clearances from Olympus Optical Co., Ltd.
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 K033225
K-number listed on FDA's recall record- Z-0327-2024 — Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
- Z-2491-2023 — Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
- Z-1048-2022 — BF-MP160F: EVIS EXERA Bronchofibervideoscope
- Z-2569-2021 — BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
- Z-3305-2018 — Bronchovideoscope BF-XP160F
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.