The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Stiletto Electrosurgical Probe.
Device ID | K052141 |
510k Number | K052141 |
Device Name: | STRYKER STILETTO ELECTROSURGICAL PROBE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Crystal Ong |
Correspondent | Crystal Ong Stryker Endoscopy 5900 OPTICAL CT. 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 | 2005-08-08 |
Decision Date | 2005-10-06 |
Summary: | summary |