510(k) K253237

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) by Elde Medikal Sanayi ve Ticaret Anonim Sirketi — Product Code GXY

K253237 is an FDA 510(k) premarket notification submitted by Elde Medikal Sanayi ve Ticaret Anonim Sirketi for the device "Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.