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510(k) K241209

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) by Cook Ireland, Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
April 30, 2024
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 Cook Ireland, Ltd.

  • K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); (June 14, 2024)
  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K213946 — Compass BDS Biliary Stent (May 9, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)
  • DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System (November 20, 2019)
  • K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (November 16, 2018)
  • K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal B (July 6, 2018)
  • K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushin (March 9, 2018)
  • K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Bilia (February 27, 2018)
  • K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set (August 1, 2017)

Other clearances for product code FCG

  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • 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)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)
  • K191472 — Biopsy Needle (January 29, 2020)