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510(k) K153763

Howell Biliary Aspiration Needle by Wilson-Cook Medical, Inc. — Product Code FCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2017
Date Received
December 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code FCK

  • K103326 — MULTIPLE BIOPSY SYSTEM (April 6, 2011)
  • K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM (September 5, 2006)
  • K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (May 30, 2006)
  • K051637 — DSNARE, MODEL 00711087 (October 31, 2005)
  • K954693 — MEHTA BRONCHIAL BIOSPY DRILL (October 23, 1995)
  • K944252 — BIOPSY DEVICE ACCESSORY (December 5, 1994)
  • K932142 — SUCTION GUILLOTINE DEVICE (September 24, 1993)
  • K911448 — MULTIPLE BIOPSY DEVICE-MBX (April 16, 1991)
  • K902910 — CYTOASPIRATOR (January 16, 1991)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)