The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Rf Coaxial Bipolar Electrodes & Cannulae.
| Device ID | K043442 |
| 510k Number | K043442 |
| Device Name: | STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean Sheppard |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-05-31 |
| Summary: | summary |