510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980356Substantially Equivalent

Cervical Cytology C-Brush Model Cmb-1010

Canadian Medical Brush, Inc., Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980356 is the FDA 510(k) clearance record for CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010, a class II device, cleared for Canadian Medical Brush, Inc. on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list one 510(k) clearance for Canadian Medical Brush, Inc. As of , FDA records show no recalls naming K980356.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Canadian Medical Brush, Inc. 2299 Drew Rd., Mississauga, CA
510(k) summary
Summary
Third party review
No

Clearances, product code HHT

Trailing 12 months

FDA records hold no clearances under product code HHT in the trailing twelve months.

FDA records show no clearances under product code HHT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260