Home / 510(k) Clearances / K923200

510(k) K923200

AMCATH DISPOSABLE CYTOLOGY BRUSH by Intl. Medical, Inc. — Product Code FDX

K923200 is an FDA 510(k) premarket notification submitted by Intl. Medical, Inc. for the device "AMCATH DISPOSABLE CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on December 7, 1992. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Intl. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1992
Date Received
June 30, 1992
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 Intl. Medical, Inc.

  • K970507 — PEAK FLOW METER (June 13, 1997)
  • K943078 — HOT BIOPSY FORCEPS (November 14, 1994)
  • K940370 — AMERICAN CATHETER E.R.C.P. CANNULA (August 17, 1994)
  • K940335 — AMERICAN CATHETER POLY-SNARE (July 21, 1994)
  • K942068 — AMERICAN CATHETER SPHINCTEROTOME (June 24, 1994)
  • K930410 — DURHAM; LUER LOCK EXTENSION SET (September 3, 1993)
  • K930406 — DURHAM; MIN BORE LUER LOCK EXTENSION SET (September 3, 1993)
  • K915142 — AMCATH DISPOSABLE BIOPSY FORCEPS (January 10, 1992)
  • K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (September 19, 1991)
  • K912605 — AMCATH DISPOSABLE MICRO SCISSORS (July 11, 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