HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L— 510(k) K090980
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K090980 for HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L, Substantially Equivalent on 2009-06-29. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code NWB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
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Adverse events under product code NWB
product code NWB- Malfunction
- 12,503
- Total
- 12,503
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.