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.
Summary
Technomed Europe's record lists six Disposable Concentric Needle Electrodes, each with a size, color and part number, from 0.30x25mm Red (TE/B50700-001) to 0.60x75mm Violet (TE/B50700-005). They're filed under IKT, diagnostic electromyograph needle electrodes.
Class II, 21 CFR 890.1385. The Neurology review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
Technomed Europe filed from Kerkrade, the Netherlands. The decision came 118 calendar days after FDA received it (November 17, 2025 to March 15, 2026).
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
- Product 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
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