Visera Elite II Video System Center— 510(k) K202646
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K202646 for Visera Elite II Video System Center, Substantially Equivalent on 2020-10-29. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hachioji-Shi, JP
Recent devices under product code FET
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- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.