The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Monopolar Single-use Hf Cable.
| Device ID | K160053 |
| 510k Number | K160053 |
| Device Name: | Monopolar Single-use HF Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Katharina Campbell |
| Correspondent | Graham Baillie 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 | 2016-01-11 |
| Decision Date | 2016-05-06 |
| Summary: | summary |