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510(k) K901435

GASTROINTESTINAL CYTOLOGY BRUSH by Telemed Systems, Inc. — Product Code FDX

K901435 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "GASTROINTESTINAL CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on July 16, 1990. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
March 26, 1990
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 Telemed Systems, Inc.

  • K020379 — PPD BALLOON DILATATION CATHETER (May 6, 2002)
  • K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (March 1, 2002)
  • K010412 — FLEXIBLE ENDOSCOPIC SCISSORS (April 2, 2001)
  • K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM (December 22, 1999)
  • K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 (December 22, 1999)
  • K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUS (January 21, 1998)
  • K974300 — TELEMED SYSTEMS RETRIEVAL BASKET (December 19, 1997)
  • K901427 — BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON (June 22, 1990)
  • K901426 — COLONIC BALLOON DILATOR (June 21, 1990)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)

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