EVIS EXERA 180 SYSTEM— 510(k) K061313
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K061313 for EVIS EXERA 180 SYSTEM, Substantially Equivalent on 2006-08-31. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- 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
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
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 K061313
K-number listed on FDA's recall record- Z-1488-2026 — Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
- Z-1489-2026 — Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
- Z-0046-2026 — EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
- Z-0051-2026 — EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
- Z-0056-2026 — EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
- Z-0061-2026 — EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
- Z-0191-2024 — EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
- Z-0332-2024 — Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
- Z-2493-2023 — Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
- Z-2016-2023 — Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
- Z-1049-2022 — BF-1TQ180: EVIS EXERA II Bronchovideoscope
- Z-2571-2021 — BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
- Z-2572-2021 — BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
- Z-3017-2020 — Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
- Z-3285-2018 — Bronchovideoscope BF-1T180
- Z-3288-2018 — Bronchovideoscope F-1TQ180
- Z-3297-2018 — Bronchovideoscope BF-P180
- Z-3301-2018 — Bronchovideoscope BF-Q180
- Z-3310-2018 — Rhino Laryngo scope ENF-VT2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061313.
Data sourced from openFDA. This site is unofficial and independent of the FDA.