The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Bipolar Applicator Celon Procurve V.
| Device ID | K172535 |
| 510k Number | K172535 |
| Device Name: | Bipolar Applicator CELON ProCurve V |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-22 |
| Decision Date | 2017-11-16 |
| Summary: | summary |