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510(k) K021525

TOPCUT by H.S. Hospital Service S.R.L. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2002
Date Received
May 10, 2002
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 H.S. Hospital Service S.R.L.

  • K020987 — BMN I TYPE MARROW ASPIRATION NEEDLE (June 25, 2002)
  • K013692 — TRAPSYSTEM SET (February 5, 2002)
  • K002944 — PRECISA BIOPSY NEEDLE (December 19, 2000)
  • K002947 — BIOMOL ASPIRATION BIOPSY NEEDLE (December 19, 2000)
  • K002946 — SILENT BIOPSY NEEDLE (December 19, 2000)

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)
  • 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)