MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES— 510(k) K023984
Substantially EquivalentThe Olympus Optical Co.
FDA 510(k) clearance K023984 for MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES, Substantially Equivalent on 2003-01-31. Applicant: The Olympus Optical Co.. Device class: 2.
Clearance details
- Applicant
- The Olympus Optical Co.
- 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 The Olympus Optical Co.
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 K023984
K-number listed on FDA's recall record- Z-0045-2026 — BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
- Z-0047-2026 — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
- Z-0054-2026 — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
- Z-0055-2026 — BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
- Z-0058-2026 — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
- Z-0059-2026 — BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
- Z-0064-2026 — BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
- Z-0065-2026 — EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
- Z-0067-2026 — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
- Z-0189-2024 — BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
- 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-2490-2023 — Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
- Z-2011-2023 — Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
- Z-2012-2023 — Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
- Z-2013-2023 — Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
- Z-2014-2023 — Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
- Z-1046-2022 — BF-MP60: OES Bronchofiberscope
- Z-1047-2022 — BF-3C160: EVIS EXERA Bronchovideoscope
- Z-2497-2021 — EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Z-2565-2021 — BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023984.
Data sourced from openFDA. This site is unofficial and independent of the FDA.