MultiGen 2 RF Generator System— 510(k) K170242
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K170242 for MultiGen 2 RF Generator System, Substantially Equivalent on 2017-05-25. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code GXD
- Device class
- Class 2
- Regulation
- 21 CFR 882.4400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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Adverse events under product code GXD
product code GXD- Injury
- 228
- Total
- 228
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.