Home / 510(k) Clearances / K112945

510(k) K112945

ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM by Inrad, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2011
Date Received
October 4, 2011
Clearance Type
Special
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.

  • K243886 — ExpressCore Biopsy Device (April 29, 2025)
  • K240429 — Trilogy Tissue Marker (November 7, 2024)
  • K183503 — EasyMark Tissue Marker (October 17, 2019)
  • 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

  • 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)
  • K243886 — ExpressCore Biopsy Device (April 29, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)