XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248— 510(k) K040358

Clearance details

Applicant

Excel Tech. , Ltd.

Product code

Code GWF

Device class

Class 2

Regulation

21 CFR 882.1870

Advisory panel

Neurology

Date received

2004-02-13

Decision date

2004-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakville, Ontario, CA

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• K242345 — Delphi Stimulator2024-11-05

• K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 1052382006-10-04
• K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES2006-08-14
• K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK10722006-04-21
• K053058 — XLTEK NEUROPATH, MODEL PK10702006-02-07
• K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK10592005-10-28

Malfunction

2,364

Other

4

Total

2,368

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1068-2015 — EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.Class II·Terminated·Natus Medical Incorporated·20150102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040358.