510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864527Substantially Equivalent

Duoceph

Gary E. Hall, Dds, Plymouth MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864527 is the FDA 510(k) clearance record for DUOCEPH, a class I device, cleared for Gary E. Hall, Dds on under FDA product code IWY (Holder, Head, Radiographic). FDA records list 2 510(k) clearances for Gary E. Hall, Dds, from to . As of , FDA records show no recalls naming K864527.

Clearance record

Decision date
Received
(51 days to decision)
Product code
IWY Holder, Head, Radiographic
Regulation
21 CFR 892.1920
Device class
Class I
Review panel
Radiology
Applicant
Gary E. Hall, Dds 46850 N. Territorial, Plymouth MI
Third party review
No

Clearances, product code IWY

Trailing 12 months

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

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