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510(k) K890203

ADMS BIOPSY NEEDLE by Advanced Diagnostic Medical Systems, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1989
Date Received
January 17, 1989
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 Advanced Diagnostic Medical Systems, Inc.

  • K882746 — ADMS SILENT NEEDLE GUN (March 17, 1989)
  • K881208 — PROBE SHEATH FOR ADMS ULTRASOUND PROBE (May 16, 1988)
  • K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE (March 2, 1988)

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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)