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510(k) K914732

CORE MEDICAL BIOPSY NEEDLE by Core Medical, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1992
Date Received
October 21, 1991
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 Core Medical, Inc.

  • K924271 — CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES (November 23, 1992)
  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)

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  • 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)