Ultrasharp Concentric Needles
by Rochester Electro-Medical, Inc. 510(k)
Active
510(k) K080914
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080914 | Date15 Jul 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IKT
- FDA applicant
- Rochester Electro Medical, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1385
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Ultrasharp Concentric Needles are diagnostic electromyograph needles used for medical procedures. These needles are designed for diagnostic purposes in electromyography, a technique that evaluates and records the electrical activity of muscles.
The device is supplied by Rochester Electro-Medical, Inc. and is authorized under FDA 510K clearance. The needles are available in various sizes as indicated by the multiple model numbers listed in the specifications. They are regulated under product code IKT and are classified as Class II medical devices.
Other devices from Rochester Electro-Medical, Inc.
Questions
AI-generated answers, 23 Sep 2026
What are Ultrasharp Concentric Needles used for?
Ultrasharp Concentric Needles are diagnostic electromyograph needles used to evaluate and record the electrical activity of muscles during medical procedures. They are specifically designed for diagnostic purposes in electromyography.
What sizes and models are available for these needles?
The Ultrasharp Concentric Needles are available in various sizes as indicated by multiple model numbers listed in the specifications. The specific model numbers can be found in the device data, which includes numerous registration numbers and FEI numbers.
What is the regulatory status of these needles?
The Ultrasharp Concentric Needles are authorized under FDA 510K clearance with a decision code of SESE (Substantially Equivalent). They are classified as Class II medical devices and regulated under product code IKT.
How are these needles supplied and what is their sterility status?
The device is supplied by Rochester Electro-Medical, Inc. The description does not specify whether the needles are supplied sterile or non-sterile, nor does it indicate if they are single-use or reusable. This information would need to be obtained directly from the manufacturer.