Pediguard Nerve Detector System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030526 FDA 510(k)
- FDA Product Code
- GWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1870 FDA 510(k)
- Regulation Number
- 882.1870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pediguard Nerve Detector System is an electrical stimulator used for evoked response. It is designed for intraoperative electromyographic surveillance to assist in the location and evaluation of spinal nerves during spinal surgery by administering low voltage electrical energy to tissues and nerves at the operative site.
This device is regulated under 21 CFR 882.1870 and received FDA 510(k) clearance under K030526. It is intended for use in a surgical setting to provide electromyographic monitoring of muscle groups associated with the operative site.
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: PEDIGUARD NERVE DETECTOR SYSTEM (K030526) — FDA 510 (k) | Innolitics, SpineGuard, Real Time Sensing DSG Technology, PediGuard, Spine, PEDIGUARD NERVE DETECTOR SYSTEM 510 (k) K030526 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030526 | Class II | Active |
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Manufacturer
- Manufacturer
- Spine Vision, Inc.
Sources (1)
- FDA 510(k) K030526 24 fields · synced Sep 21, 2026