The following data is part of a premarket notification filed by Livsmed Inc. with the FDA for Artisential Laparoscopic Instruments-electrodes.
| Device ID | K220384 |
| 510k Number | K220384 |
| Device Name: | ArtiSential Laparoscopic Instruments-Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, KR 13516 |
| Contact | Dong Wook Lee |
| Correspondent | Dong Wook Lee LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, KR 13516 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-10 |
| Decision Date | 2022-02-24 |