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510(k) K171607

Bronchi and Gastrointestinal Cytology Brush by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2017
Date Received
June 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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  • K172288 — Fusion OMNI Sphincterotome (April 17, 2018)
  • K171993 — Zimmon Needle Knife Papillotome (August 17, 2017)
  • K121505 — DISPOSABLE HEMOSTASIS CHIP (August 31, 2012)
  • K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (April 27, 2012)

Other clearances for product code FDX

  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191485 — Deflectable Brush Biopsy Set (June 26, 2019)
  • K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set (May 1, 2019)
  • K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (February 8, 2019)
  • K172663 — Cytology Brush (March 5, 2018)
  • K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (December 29, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)
  • K103437 — US ENDOSCOPY CYTOLOGY BRUSH (December 23, 2010)