510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820027Substantially Equivalent

Modified Ea 50

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

K820027 is the FDA 510(k) clearance record for MODIFIED EA 50, a class I device, cleared for Surgipath on under FDA product code HZJ (Stain, Papanicolau). FDA records list 12 510(k) clearances for Surgipath, from to . As of , FDA records show no recalls naming K820027.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HZJ Stain, Papanicolau
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Surgipath 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HZJ

Trailing 12 months

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

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