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510(k) K151889

Infinity ERCP Sampling Device by United States Endoscopy Group, Inc. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2015
Date Received
July 10, 2015
Clearance Type
Special
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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Other clearances for product code FDX

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  • 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)
  • K103437 — US ENDOSCOPY CYTOLOGY BRUSH (December 23, 2010)