Stimuplex HNS-12, Model 4892098
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052313 FDA 510(k)
- FDA Product Code
- BXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2775 FDA 510(k)
- Regulation Number
- 868.2775 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stimuplex HNS-12, Model 4892098 is a battery-powered nerve stimulator designed for peripheral nerve stimulation. It facilitates precise localisation of nerves during regional anaesthesia procedures, enabling targeted anaesthetic administration.
This device is intended for single-use in clinical settings and is classified as a Class II medical device under FDA regulations. It operates within the scope of 21 CFR 868.2775 for electrical peripheral nerve stimulators and has received FDA 510(k) clearance via an abbreviated review process. Supplied sterile, it is regulated under the Medical Device Directive (MDD) in Europe.
Frequently asked questions
What clinical procedure is the Stimuplex HNS-12 primarily used for, and how does it assist in that process?
The Stimuplex HNS-12 is designed for peripheral nerve stimulation during regional anaesthesia procedures. It helps clinicians locate nerves with precision, allowing for targeted administration of anaesthetic agents. This ensures accurate nerve blockade, improving the effectiveness and safety of the anaesthesia process.
Is the Stimuplex HNS-12 intended for reuse in clinical settings, or is it meant to be used only once?
The Stimuplex HNS-12 is explicitly intended for single-use in clinical settings. This design choice aligns with best practices for sterile medical devices to minimize infection risks and ensure consistent performance.
How is the Stimuplex HNS-12 supplied, and does it come in sterile packaging?
Yes, the Stimuplex HNS-12 is supplied sterile, ready for immediate clinical use without additional sterilization. This ensures safety and reliability in procedures requiring aseptic conditions.
What regulatory pathways has the Stimuplex HNS-12 followed in the U.S. and Europe, and what does that mean for its use?
In the U.S., the Stimuplex HNS-12 received FDA 510(k) clearance through an abbreviated review process, confirming it is *substantially equivalent* to a predicate device under 21 CFR 868.2775 for electrical peripheral nerve stimulators. In Europe, it complies with the Medical Device Directive (MDD), classifying it as a Class II device. These pathways ensure it meets stringent safety and performance standards for its intended use in nerve stimulation during regional anaesthesia.
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: Stimuplex® HNS 12 Nerve Stimulator (4892098) - BBraunUSA.com, STIMUPLEX HNS-12, MODEL 4892098 (K052313) — FDA 510 (k) | Innolitics, HNS12 Nerve Stimulator for Regional Anaesthesia - Home - Stockert
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K052313 | Class II | Active |
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Manufacturer
- Manufacturer
- Stockert GmbH
Sources (2)
- FDA 510(k) K052313 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026