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.
Summary
Finemedix's ClearTip TBNA Type is filed under product code KTI (Bronchoscope Accessory). The record doesn't spell out TBNA or describe the device beyond its name and that code name.
Class II, 21 CFR 874.4680. The record lists Ear, Nose, and Throat as the classification panel, but the Anesthesiology review panel handled this Traditional 510(k).
Finemedix filed from Daegu, South Korea. Review took 338 calendar days (May 13, 2025 to April 16, 2026).
Clearance details
- Applicant
- Finemedix Co., Ltd.
- Product code
- Product 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
Recent devices under product code KTI
view all- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more
- K254040 — LungFlow Basket Catheter
- K251402 — LIA-1 Catheter (542-1)
- K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
- K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
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.