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510(k) K021998

HORIZONS CYTOLOGY BRUSH by Horizons Intl. Corp. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2002
Date Received
June 19, 2002
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.

Other clearances by Horizons Intl. Corp.

  • K083049 — TORNADO ROTATABEL SNARE AND POLYP CATCHER (December 23, 2008)
  • K022243 — HORIZONS REUSABLE HOT BIOPSY FORCEPS (October 25, 2002)
  • K022268 — HORIZONS REUSABLE POLYPECTOMY SNARES (October 25, 2002)
  • K022546 — HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (August 12, 2002)
  • K021706 — HORIZONS HOT BIOPSY FORCEPS (June 21, 2002)
  • K011667 — HORIZONS INTERNATIONAL POLYPECTOMY SNARES (August 16, 2001)
  • K010448 — HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (May 16, 2001)
  • K002236 — HORIZONS PAPILLOTOME (January 23, 2001)
  • K002235 — HORIZONS ERCP CANNULA (January 23, 2001)

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  • K191485 — Deflectable Brush Biopsy Set (June 26, 2019)
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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)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)