Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more— 510(k) K253581
Substantially EquivalentTechnomed Europe
FDA 510(k) clearance K253581 for Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more, Substantially Equivalent on 2026-03-15. Applicant: Technomed Europe. Device class: 2.
Clearance details
- Device name as filed
- Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
- Applicant
- Technomed Europe
- Product code
- Code IKT
- Device class
- Class 2
- Regulation
- 21 CFR 890.1385
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kerkrade, NL
Recent devices under product code IKT
view all- K173815 — Allergan Botox Needle Electrode
- K161430 — Myoject Luer Lock Needle Electrode
- K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
- K120342 — EMG RECORDING ELECTRODE ASSEMBLY
More clearances from Technomed Europe
view allData sourced from openFDA. This site is unofficial and independent of the FDA.