STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
FDA 510(k) clearance K071482 · decided 2007-12-20
Clearance details
- K-number
- K071482
- Device name
- STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
- Applicant
- Synergetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-30
- Decision date
- 2007-12-20
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- O' Fallon, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U recall (Z-0584-2017) | Stryker Instruments Div. of Stryker Corporation | 2016-11-16 |