Atlas FDA

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)

FDA 510(k) clearance K253581 · decided 2026-03-15

Clearance details

K-number
K253581
Device name
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
Decision
Substantially Equivalent
Date received
2025-11-17
Decision date
2026-03-15
Days to decision
118 days
Clearance type
Traditional
Product code
IKT
Device class
2
Regulation number
890.1385
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Kerkrade, NL
Third-party review
No
Expedited review
No

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TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (K111131)Carefusion 209, Inc.2011-06-17
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE (K092973)Bionen S.A.S.2010-10-07
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (K093825)Ambu A/S2010-01-13
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (K091410)Spes Medica Srl2009-08-11
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R (K091055)Rhythmlink International, LLC2009-06-23
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R (K091056)Rhythmlink International, LLC2009-06-23

Recalls involving this device

No recalls on record reference this clearance.