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510(k) K251478

ClearTip TBNA Type by Finemedix Co., Ltd. — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
May 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope Accessory
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Finemedix Co., Ltd.

  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K231267 — ClearTip (June 30, 2023)
  • K202616 — ClearCap Distal Attachment (February 19, 2021)
  • K200217 — ClearEndoclip (October 5, 2020)
  • K183021 — ClearEndoclip (June 28, 2019)
  • K183289 — ClearGrasp Snare (March 6, 2019)
  • K181690 — Clear-Jet Injection Catheter (December 21, 2018)
  • K180363 — Clear-Tip EUS-FNA (November 1, 2018)

Other clearances for product code KTI

  • K254040 — LungFlow Basket Catheter (March 12, 2026)
  • K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
  • K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
  • K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA (July 29, 2025)
  • K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
  • K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
  • K231818 — METIC™- Airway Balloon Catheter (November 15, 2023)
  • K230778 — EndoCore (September 25, 2023)
  • K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
  • K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)