Re-Usable Bipolar Concentric Needle (237-Xxx-24 +3 more)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960591 FDA 510(k)
- FDA Product Code
- IKT FDA 510(k)
- Models / Variants
- 237-Xxx-24 FDA 510(k)237-Xxx-24stp FDA 510(k)237-Xxx-24tp FDA 510(k)237-Xxx-24stp FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1385 FDA 510(k)
- Regulation Number
- 890.1385 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reusable Bipolar Concentric Needle is a diagnostic electromyograph electrode used for medical procedures. It is designed for repeated use in physical medicine applications.
This device is supplied as reusable and requires appropriate storage between uses. It has FDA 510K clearance K960591 and is classified under product code IKT for physical medicine applications.
Frequently asked questions
What is the Reusable Bipolar Concentric Needle used for?
The Reusable Bipolar Concentric Needle is a diagnostic electromyograph electrode designed for medical procedures in physical medicine applications. It is intended for repeated use in these diagnostic procedures.
How is the Reusable Bipolar Concentric Needle supplied?
The device is supplied as reusable and requires appropriate storage between uses. It is designed to be used multiple times following proper sterilization and storage protocols.
What are the model numbers available for the Reusable Bipolar Concentric Needle?
The Reusable Bipolar Concentric Needle is available in multiple model numbers including 237-XXX-24, 237-XXX-24STP, 237-XXX-24TP, and 237-XXX-24STP, each designed for specific applications.
What is the regulatory status of this device?
The Reusable Bipolar Concentric Needle has FDA 510K clearance K960591 and is classified under product code IKT for physical medicine applications. It is a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Re-usable Bipolar Concentric Needle (237-xxx-24,237-xxx-24stp, 237-xxx ..., RE-USABLE BIPOLAR CONCENTRIC NEEDLE (237-XXX-24,237-XXX… - FDA.report, fda.innolitics.com, ULTRASHARP CONCENTRIC NEEDLES (K080914) — FDA 510(k) | Innolitics, Chalgren Enterprises, Inc. - FDA 510 (k) Cleared Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960591 | Class II | Active |
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Manufacturer
- Manufacturer
- Chalgren Enterprises, Inc.
Sources (1)
- FDA 510(k) K960591 24 fields · synced Sep 25, 2026