The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Electrodes With Hf Cable.
| Device ID | K171965 |
| 510k Number | K171965 |
| Device Name: | Resection Electrodes With HF Cable |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg, DE 22045 |
| Contact | Jan-oliver Upmeier |
| Correspondent | Dolan Mills Gyrus ACMI, Inc. 136 Turnpike Road 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 | 2017-06-30 |
| Decision Date | 2017-09-28 |
| Summary: | summary |