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510(k) K212819

Disposable Biopsy Refill Needle by Suzhou Leapmed Healthcare Corporation — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2022
Date Received
September 3, 2021
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 Suzhou Leapmed Healthcare Corporation

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  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K212284 — Disposable Automatic Core Biopsy Instrument (November 10, 2021)

Other clearances for product code FCG

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  • 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)
  • 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)