The following data is part of a premarket notification filed by Stryker Instruments, Instruments Div. with the FDA for Stryker Venom Electrodes And Cannulae.
| Device ID | K123178 |
| 510k Number | K123178 |
| Device Name: | STRYKER VENOM ELECTRODES AND CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Christina Mckee |
| Correspondent | Christina Mckee STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-03-28 |
| Summary: | summary |