510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934468Substantially Equivalent

Slip-on Fixation Splint (Sfs)

Gatewood Splints, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934468 is the FDA 510(k) clearance record for SLIP-ON FIXATION SPLINT (SFS), a class I device, cleared for Gatewood Splints on under FDA product code EHO (Bar, Preformed). FDA records list one 510(k) clearance for Gatewood Splints. As of , FDA records show no recalls naming K934468.

Clearance record

Decision date
Received
(329 days to decision)
Product code
EHO Bar, Preformed
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Gatewood Splints 5200 Meadowcreek Dr., #1118, Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code EHO

Trailing 12 months

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

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