510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842053Substantially Equivalent

Paraplast Extra Tissue Embedding Med.

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

K842053 is the FDA 510(k) clearance record for PARAPLAST EXTRA TISSUE EMBEDDING MED., a class I device, cleared for Sherwood Medical Co. on under FDA product code KEO (Formulations, Paraffin, All). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K842053.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KEO Formulations, Paraffin, All
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Sherwood Medical Co. 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