The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Electrodes.
| Device ID | K161600 |
| 510k Number | K161600 |
| Device Name: | Resection Electrodes |
| Classification | Electrode, Electrosurgical |
| Applicant | OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg, DE 22045 |
| Contact | Katharina Campbell |
| Correspondent | Dolan Mills GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-09 |
| Decision Date | 2016-09-06 |
| Summary: | summary |