Identifiers
- 510(k) Number
- K022029 FDA 510(k)
- FDA Product Code
- BSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5150 FDA 510(k)
- Regulation Number
- 868.5150 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quincke Spinal Needle is a conduction needle, specifically designed for anesthetic procedures. It is classified as a needle with or without an introducer, intended for spinal anesthesia applications under the regulatory category of Class II medical devices. This device facilitates the administration of local anesthetics into the spinal canal for regional analgesia or anesthesia during surgical or diagnostic procedures.
The Quincke Spinal Needle is supplied as a single-use, non-sterile device and is regulated under FDA 510K and MDR authorizations. It is intended for use in controlled clinical settings, such as operating rooms or procedural suites, where aseptic techniques are maintained. The device is available in various sizes and configurations, as indicated by the associated registration numbers, and must be sterilized by the user prior to application. No specific MRI safety information is provided, and its use adheres to standard spinal anesthesia protocols.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K022029 | Class II | Active |
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Manufacturer
- Manufacturer
- Epimed International, Inc.
Sources (2)
- FDA 510(k) K022029 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026