Atlas FDA

TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

FDA 510(k) clearance K111131 · decided 2011-06-17

Clearance details

K-number
K111131
Device name
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
Applicant
Carefusion 209, Inc.
Decision
Substantially Equivalent
Date received
2011-04-21
Decision date
2011-06-17
Days to decision
57 days
Clearance type
Special
Product code
IKT
Device class
2
Regulation number
890.1385
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Middleton, WI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Carefusion 209

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K253581)Technomed Europe2026-03-15
Allergan Botox Needle Electrode (K173815)Natus Manufacturing Limited2018-06-29
Myoject Luer Lock Needle Electrode (K161430)Natus Manufacturing Limited2017-03-02
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (K152984)Bio Protech, Inc.2016-06-03
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 (K143433)Natus Manufacturing Limited2015-08-28
EMG RECORDING ELECTRODE ASSEMBLY (K120342)Rhythmlink International, LLC2012-06-22
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (K112034)Carefusion 209, Inc.2011-08-12
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.