Medispine Spinal Needle, Glospine Spinal Needle
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212982 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 Medispine and Glospine Spinal Needles are conduction needles designed for anesthetic administration during spinal procedures. These devices facilitate the delivery of local anesthetics into the spinal canal to induce regional anesthesia, aiding in pain management for surgical or diagnostic interventions.
These spinal needles are intended for single-use in sterile clinical settings, such as operating rooms or procedural suites. They are classified as Class II devices under FDA regulations and comply with the Medical Device Regulation (MDR). Supplied in sterile packaging, they are regulated under the FDA’s 510(k) pathway with a determination of Substantially Equivalent to predicate devices, as reviewed by the Anesthesiology Device Advisory Committee.
Frequently asked questions
Are the Medispine and Glospine Spinal Needles reusable or intended for single-use only?
The Medispine and Glospine Spinal Needles are explicitly designed for single-use only in sterile clinical settings like operating rooms or procedural suites. This ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.
How are these spinal needles packaged, and what does that mean for clinical workflow?
They are supplied in sterile packaging, which means they are pre-sterilized and ready for immediate use without additional processing. This streamlines workflows in sterile environments like ORs or procedural suites, reducing contamination risks and saving time.
What regulatory pathway was used for FDA clearance of these spinal needles, and what does that imply?
The Medispine and Glospine Spinal Needles were cleared via the FDA’s 510(k) pathway, determined to be *Substantially Equivalent* to predicate devices. This was reviewed by the Anesthesiology Device Advisory Committee (AN) under the classification of Class II devices, ensuring compliance with FDA regulations for conduction needles used in anesthetic administration.
Are there different sizes or models available for these spinal needles, and if so, how are they differentiated?
The provided data lists multiple FEI numbers (e.g., 3000204727, 3030626857) and registration numbers, which typically correspond to distinct sizes, gauges, or configurations of spinal needles. While exact specifications (e.g., gauge, length) aren’t detailed here, these identifiers imply variability in models to accommodate different clinical needs, such as patient anatomy or procedural requirements.
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 | K212982 | Class II | Active |
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Manufacturer
- Manufacturer
- Global Medikit Limited
Sources (2)
- FDA 510(k) K212982 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026