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510(k) K243886

ExpressCore Biopsy Device by Inrad, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2025
Date Received
December 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Inrad, Inc.

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  • K112945 — ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 1 (November 3, 2011)
  • K093399 — PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018 (November 19, 2009)
  • K093256 — SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 99 (November 17, 2009)
  • K090611 — REVOLUTION FULL CORE BIOPSY (June 4, 2009)
  • K063238 — ULTRACLIP II WING AND ULTRACLIP II COIL (January 30, 2007)
  • K042341 — ULTRACLIP II US (September 20, 2004)
  • K041201 — ULTRACLIP II MR (June 3, 2004)
  • K000612 — ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE (April 24, 2000)

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