510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853497Substantially Equivalent

Prefilled Specimen Jars 10% Neutral Buf-Formalin

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

K853497 is the FDA 510(k) clearance record for PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN, a class I device, cleared for Surgipath Medical Industries, Inc. on under FDA product code IFP (Formalin, Neutral Buffered). FDA records list 30 510(k) clearances for Surgipath Medical Industries, Inc., from to . As of , FDA records show no recalls naming K853497.

Clearance record

Decision date
Received
(8 days to decision)
Product code
IFP Formalin, Neutral Buffered
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Surgipath Medical Industries, Inc. P.O. Box 769, Grayslake IL
Third party review
No

Clearances, product code IFP

Trailing 12 months

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

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