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510(k) K250994

ClearTip FNA and FNB Types by Finemedix Co., Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2025
Date Received
April 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Finemedix Co., Ltd.

  • 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 FCG

  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K241209 — EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (July 29, 2024)
  • K231422 — Precision GI (August 28, 2023)
  • K231267 — ClearTip (June 30, 2023)
  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K212423 — EndoDrill® Model X (March 29, 2023)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)
  • K191472 — Biopsy Needle (January 29, 2020)