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510(k) K894863

WILTEK CYTOLOGY BRUSH by Wiltek Medical, Inc. — Product Code FDX

K894863 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1989
Date Received
July 31, 1989
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 Wiltek Medical, Inc.

  • K990231 — WILTEK HOT BIOPSY FORCEPS (April 13, 1999)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K930419 — WILTEK BIOPSY FORCEPS (June 1, 1993)
  • K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
  • K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
  • K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)

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)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)

FDA data resources