OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190— 510(k) K111425
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K111425 for OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190, Substantially Equivalent on 2012-04-20. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- 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
- Traditional
- Location
- Center Valley, PA, US
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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 K111425
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 K111425.
Data sourced from openFDA. This site is unofficial and independent of the FDA.