The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Electrodes.
Device ID | K152092 |
510k Number | K152092 |
Device Name: | Resection Electrodes |
Classification | Electrode, Electrosurgical, Active, Urological |
Applicant | Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg, DE 22045 |
Contact | Katharina Schnackenburg |
Correspondent | Graham Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
Product Code | FAS |
Subsequent Product Code | FJL |
Subsequent Product Code | HIH |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-28 |
Decision Date | 2015-10-26 |
Summary: | summary |