TECA Elite Disposable Monopolar Needles
510(k) K111131
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111131 | Date17 Jun 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Teca (Tm) Elite Disposable Monopolar Needles
- 510(k) Number
- FDA Product Code
- IKT
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1385
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TECA Elite Disposable Monopolar Needles are classified as diagnostic electromyograph needles, designed for electromyographic (EMG) testing. These single-use, disposable electrodes are intended for sensing subcutaneous bioelectrical activity or stimulating nerve and muscular responses through percutaneous insertion into muscle tissue. They facilitate differentiation between individual motor units during diagnostic assessments.
These needles are supplied as sterile, single-use devices and are intended for use in physical medicine settings. They comply with FDA 510(k) clearance under product code IKT, classified as Class II with special controls. Needles are packaged for individual use and must be stored according to manufacturer guidelines to maintain sterility. No MRI safety information is specified, and sizes are not detailed in the provided data.
Other devices from Carefusion 209, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the TECA Elite Disposable Monopolar Needles used for?
These needles are designed specifically for electromyographic (EMG) testing. They are used to sense bioelectrical activity beneath the skin or stimulate nerve and muscle responses by being inserted into muscle tissue. This helps clinicians differentiate between individual motor units during diagnostic assessments in physical medicine.
Are the TECA Elite Disposable Monopolar Needles single-use or reusable?
The TECA Elite Disposable Monopolar Needles are explicitly designed for single-use only. This ensures sterility and reduces the risk of cross-contamination between patients, adhering to best practices in medical diagnostics.
How should these needles be stored to maintain sterility?
To maintain sterility, these needles must be stored according to the manufacturer’s guidelines. Typically, this involves keeping them in their original, unopened packaging in a clean, dry environment, away from direct sunlight and extreme temperatures. Always follow the instructions provided by Carefusion 209, Inc.
Are there different sizes or models available for the TECA Elite Disposable Monopolar Needles?
The provided data does not specify the exact sizes or models available for the TECA Elite Disposable Monopolar Needles. For precise details on gauge, length, or other variations, refer to the manufacturer’s product documentation or contact Carefusion 209, Inc. directly.
Can these needles be used in MRI environments?
The provided information does not include any details regarding MRI safety for the TECA Elite Disposable Monopolar Needles. If MRI compatibility is required, consult the manufacturer’s instructions or safety data sheet to ensure safe use in magnetic resonance imaging environments.