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510(k) K024120

MODIFICATION TO TEMNO BIOPSY NEEDLES by Allegiance Healthcare Corp. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2003
Date Received
December 16, 2002
Clearance Type
Special
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 Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
  • K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)
  • K020818 — POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (July 5, 2002)

Other clearances for product code FCG

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  • 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)