STRYKER VENOM ELECTRODES AND CANNULAE
FDA 510(k) clearance K123178 · decided 2013-03-28
Clearance details
- K-number
- K123178
- Device name
- STRYKER VENOM ELECTRODES AND CANNULAE
- Applicant
- Stryker Instruments, Instruments Div.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-09
- Decision date
- 2013-03-28
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.