510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821497Substantially Equivalent

Disposable Surgical Scrub Brushes

Medical Systems Research, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821497 is the FDA 510(k) clearance record for DISPOSABLE SURGICAL SCRUB BRUSHES, a class I device, cleared for Medical Systems Research on under FDA product code GEC (Brush, Scrub, Operating-Room). FDA records list 2 510(k) clearances for Medical Systems Research, from to . As of , FDA records show no recalls naming K821497.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GEC Brush, Scrub, Operating-Room
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medical Systems Research 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GEC

Trailing 12 months

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

FDA records show no clearances under product code GEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEC, 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