The following data is part of a premarket notification filed by Stryker with the FDA for Stryker 90-s Max Serfas Energy Probe.
Device ID | K171391 |
510k Number | K171391 |
Device Name: | Stryker 90-S Max SERFAS Energy Probe |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
Contact | Ben Krebs |
Correspondent | Ben Krebs Stryker 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 | 2017-05-11 |
Decision Date | 2018-01-26 |
Summary: | summary |