Home / 510(k) Clearances / K800966

510(k) K800966

M.R. ASSOC. CYTOLOGY BRUSHES by Mr Associates, Inc. — Product Code FDX

K800966 is an FDA 510(k) premarket notification submitted by Mr Associates, Inc. for the device "M.R. ASSOC. CYTOLOGY BRUSHES". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Mr Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 23, 1980
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 Mr Associates, Inc.

  • K800963 — BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. (May 8, 1980)
  • K800974 — M.R. ASSOC. POWER CORD (May 8, 1980)
  • K800969 — M.R. ASSOC. CANNULAS (May 8, 1980)
  • K800967 — M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS (May 8, 1980)
  • K800968 — M.R. ASSOC. RAT TOOTH GRASP FORCEPS (May 8, 1980)
  • K800962 — M.R. ASSOC. WASHING TUBE/MEASURING TUBE (May 8, 1980)
  • K800972 — M.R. ASSOC. TRIPOD GRASPING FORCEPS (May 8, 1980)
  • K800964 — M.R. ASSOC. BALL TYPE COAGULATOR (May 8, 1980)
  • K800973 — M.R. ASSOC. HOT BIOPSY FORCEPS (May 8, 1980)
  • K800975 — M.R. ASSOC. TRUE-FEEL HANDLE (May 8, 1980)

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