Cascade IOMAX Intraoperative Monitor— 510(k) K162199
Substantially EquivalentCadwell Industries, Inc.
FDA 510(k) clearance K162199 for Cascade IOMAX Intraoperative Monitor, Substantially Equivalent on 2017-03-02. Applicant: Cadwell Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Cadwell Industries, Inc.
- Product code
- Product code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennewick, WA, US
Recent devices under product code GWF
view allMore clearances from Cadwell Industries, Inc.
view allAdverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162199
K-number listed on FDA's recall record- Z-0141-2027 — Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system
- Z-2349-2024 — Cascade IOMAX Cortical Module, REF: 190296-200
- Z-1882-2024 — Cascade IOMAX Cortical Module, REF: 190296-200
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162199.
Data sourced from openFDA. This site is unofficial and independent of the FDA.