Clearance Summary
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) received FDA 510(k) clearance under submission number K253237, sponsored by Elde Medikal Sanayi ve Ticaret Anonim Sirketi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-05-08.
- Submission: K253237
- Applicant / Sponsor: Elde Medikal Sanayi ve Ticaret Anonim Sirketi
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2026-05-08
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.