510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893772Substantially Equivalent

Tissue Embedding Medium

Stephens Scientific, Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893772 is the FDA 510(k) clearance record for TISSUE EMBEDDING MEDIUM, a class I device, cleared for Stephens Scientific on under FDA product code KEO (Formulations, Paraffin, All). FDA records list 4 510(k) clearances for Stephens Scientific, from to . As of , FDA records show no recalls naming K893772.

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
Stephens Scientific 7 Astro Pl., P.O. Box 1116, Denville NJ
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