Home / 510(k) Clearances / K942144

510(k) K942144

URETHRA-BRUSH by Rovers Diagnostic Devices — Product Code FDX

K942144 is an FDA 510(k) premarket notification submitted by Rovers Diagnostic Devices for the device "URETHRA-BRUSH". The FDA issued a decision of Substantially Equivalent on June 27, 1994. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Rovers Diagnostic Devices has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1994
Date Received
May 3, 1994
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 Rovers Diagnostic Devices

  • K941472 — CERVEX-BRUSH PAP KIT (February 28, 1995)
  • K942843 — CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY (December 8, 1994)

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