ClearTip TBNA Type— 510(k) K251478
Substantially EquivalentFinemedix Co., Ltd.
FDA 510(k) clearance K251478 for ClearTip TBNA Type, Substantially Equivalent on 2026-04-16. Applicant: Finemedix Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Finemedix Co., Ltd.
- 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
- Daegu, KR
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More clearances from Finemedix Co., Ltd.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.