EVIS EXERA III VIDEO SYSTEM— 510(k) K121959
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K121959 for EVIS EXERA III VIDEO SYSTEM, Substantially Equivalent on 2013-01-10. 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
- Center Valley, PA, US
Recent devices under product code EOQ
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view all- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
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- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
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 K121959
K-number listed on FDA's recall record- Z-0049-2026 — EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
- Z-0050-2026 — BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- Z-0053-2026 — EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
- Z-0060-2026 — BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-0063-2026 — EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
- Z-0192-2024 — EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
- 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-2496-2023 — Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
- Z-2015-2023 — Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
- 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 K121959.
Data sourced from openFDA. This site is unofficial and independent of the FDA.