BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES— 510(k) K963033
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K963033 for BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES, Substantially Equivalent on 1996-09-09. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- 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 America, Inc.
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 K963033
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-0337-2024 — Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
- Z-2503-2023 — Olympus Bronchovideoscope, Models BF-3C160.
- Z-3286-2018 — Bronchovidescope BF-1T240
- Z-3289-2018 — Bronchovideoscope BF-240
- Z-3298-2018 — Bronchovideoscope BF-P240
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963033.
Data sourced from openFDA. This site is unofficial and independent of the FDA.