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510(k) K250993

Single Use Cytology Brush V (BC-V600P-3010) by Olympus Medical Systems Corporation — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
March 31, 2025
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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  • K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (September 18, 2025)

Other clearances for product code FDX

  • 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)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)
  • K103437 — US ENDOSCOPY CYTOLOGY BRUSH (December 23, 2010)