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510(k) K243886

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

K243886 is an FDA 510(k) premarket notification submitted by Inrad, Inc. for the device "ExpressCore Biopsy Device". The FDA issued a decision of Substantially Equivalent on April 29, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Inrad, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K240429 — Trilogy Tissue Marker (November 7, 2024)
  • K183503 — EasyMark Tissue Marker (October 17, 2019)
  • 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)

Other clearances for product code KNW

  • K261196 — Promisemed VeriEcto Automatic Biopsy Needles (May 12, 2026)
  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252681 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (December 12, 2025)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)
  • K244018 — Disposable Biopsy Needle (July 22, 2025)
  • K243296 — Disposable Biopsy Needle (July 11, 2025)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)

FDA data resources