510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092041Substantially Equivalent

Stellar Fiducial Marker, Model Gfmia

Stellar Medical Corp., Hudson FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092041 is the FDA 510(k) clearance record for STELLAR FIDUCIAL MARKER, MODEL GFMIA, a class II device, cleared for Stellar Medical, LLC on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 2 510(k) clearances for Stellar Medical, LLC, from to . As of , FDA records show no recalls naming K092041.

Clearance record

Decision date
Received
(87 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Stellar Medical, LLC 12738 Buckhorn Dr., Hudson FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYE

Trailing 12 months
16 clearances under product code IYE in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260