The following data is part of a premarket notification filed by Livsmed Inc. with the FDA for Artisential Trocar.
| Device ID | K212500 |
| 510k Number | K212500 |
| Device Name: | ArtiSential Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-12-03 |