510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883514Substantially Equivalent

Exakt Cutting & Grinding System

Exakt Medical Instruments, Inc., Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883514 is the FDA 510(k) clearance record for EXAKT CUTTING & GRINDING SYSTEM, a class I device, cleared for Exakt Medical Instruments, Inc. on under FDA product code IDP (Microtome, Cryostat). FDA records list one 510(k) clearance for Exakt Medical Instruments, Inc. As of , FDA records show no recalls naming K883514.

Clearance record

Decision date
Received
(12 days to decision)
Product code
IDP Microtome, Cryostat
Regulation
21 CFR 864.3010
Device class
Class I
Review panel
Pathology
Applicant
Exakt Medical Instruments, Inc. 1000 S. Mckinley P.O.Box, Oklahoma City OK
Third party review
No

Clearances, product code IDP

Trailing 12 months

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

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