510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831580Substantially Equivalent

Paraffin Infiltration Medium

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

K831580 is the FDA 510(k) clearance record for PARAFFIN INFILTRATION MEDIUM, a class I device, cleared for Surgipath Medical Industries, Inc. on under FDA product code KEO (Formulations, Paraffin, All). FDA records list 30 510(k) clearances for Surgipath Medical Industries, Inc., from to . As of , FDA records show no recalls naming K831580.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KEO Formulations, Paraffin, All
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Surgipath Medical Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEO

Trailing 12 months

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

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