TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005— 510(k) K082720
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K082720 for TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005, Substantially Equivalent on 2008-11-05. 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 K082720
K-number listed on FDA's recall record- Z-0340-2024 — Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
- Z-2495-2023 — Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
- Z-3311-2018 — Airway Mobilescope MAF-TM
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.