ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)— 510(k) K190744
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K190744 for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A), Substantially Equivalent on 2019-08-29. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hamburg, DE
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Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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 K190744
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 K190744.
Data sourced from openFDA. This site is unofficial and independent of the FDA.