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 |