510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810323Substantially Equivalent

Acrytol, Mounting Medium

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

K810323 is the FDA 510(k) clearance record for ACRYTOL, MOUNTING MEDIUM, a class I device, cleared for Surgipath on under FDA product code KEP (Media, Mounting, Oil Soluble). FDA records list 12 510(k) clearances for Surgipath, from to . As of , FDA records show no recalls naming K810323.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KEP Media, Mounting, Oil Soluble
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Surgipath 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEP

Trailing 12 months

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

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