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 |