STRYKER INTERVENTIONAL PAIN RF GENERATOR
FDA 510(k) clearance K032601 · decided 2004-04-01
Clearance details
- K-number
- K032601
- Device name
- STRYKER INTERVENTIONAL PAIN RF GENERATOR
- Applicant
- Valley Forge Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-25
- Decision date
- 2004-04-01
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oaks, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker recall (Z-0915-2011) | Stryker Instruments Div. of Stryker Corporation | 2011-01-18 |