510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842679Substantially Equivalent

Esophageal Dilator Set

Mill-Rose Laboratory, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842679 is the FDA 510(k) clearance record for ESOPHAGEAL DILATOR SET, a class II device, cleared for Mill-Rose Laboratory on under FDA product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology). FDA records list 46 510(k) clearances for Mill-Rose Laboratory, from to . As of , FDA records show no recalls naming K842679.

Clearance record

Decision date
Received
(84 days to decision)
Product code
FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Regulation
21 CFR 876.5365
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mill-Rose Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FAT

Trailing 12 months

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

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