Medical Device
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K944649Substantially Equivalent

Mill-Rose Harrell Bronchial Brush

Mill-Rose Laboratory, Mentor OH / Traditional, Substantially Equivalent

K944649 is the FDA 510(k) clearance record for MILL-ROSE HARRELL BRONCHIAL BRUSH, a class II device, cleared for Mill-Rose Laboratory on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 46 510(k) clearances for Mill-Rose Laboratory, from to . As of , FDA records show no recalls naming K944649.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EOQ Bronchoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Mill-Rose Laboratory 7310 Corporate Blvd., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code EOQ

Trailing 12 months
11 clearances under product code EOQ in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EOQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20262
May 20261
June 20261
July 20262
August 20260
September 20263
October 20260