Rhino-Laryngo Fiberscope Olympus ENF-GP2— 510(k) K181240
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K181240 for Rhino-Laryngo Fiberscope Olympus ENF-GP2, Substantially Equivalent on 2018-10-04. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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 K181240
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181240.
Data sourced from openFDA. This site is unofficial and independent of the FDA.