ViziShot 2 FLEX— 510(k) K193517
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K193517 for ViziShot 2 FLEX, Substantially Equivalent on 2020-03-18. Applicant: Olympus Surgical Technologies America. Device class: 2.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code KTI
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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Adverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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 K193517
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 K193517.
Data sourced from openFDA. This site is unofficial and independent of the FDA.