The following data is part of a premarket notification filed by Adeor Medical Ag with the FDA for Adeor Medical Nxt Non-stick Bipolar Forceps, Adeor Medical Nxt Single-use Non-stick Bipolar Forceps.
| Device ID | K191847 |
| 510k Number | K191847 |
| Device Name: | Adeor Medical Nxt Non-stick Bipolar Forceps, Adeor Medical Nxt Single-Use Non-stick Bipolar Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Adeor Medical AG Biberger Str. 93 Unterhaching, DE 82008 |
| Contact | Florian Gehrmann |
| Correspondent | Cassie Sopko JALEX Medical 30311 Clemens Rd Suite 5D Westlake, OH 44145 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-10 |
| Decision Date | 2020-05-22 |