The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Serfas 90-s Electrosurgical Probe.
| Device ID | K160050 |
| 510k Number | K160050 |
| Device Name: | SERFAS 90-S Electrosurgical Probe |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STRYKER CORPORATION 5900 Optical Court San Jose, CA 95138 |
| Contact | Somi Ekwealor |
| Correspondent | Somi Ekwealor STRYKER CORPORATION 5900 Optical Court San Jose, CA 95138 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-11 |
| Decision Date | 2016-05-03 |
| Summary: | summary |