The following data is part of a premarket notification filed by Viol Co., Ltd. with the FDA for Sylfirm X.
| Device ID | K213612 |
| 510k Number | K213612 |
| Device Name: | SYLFIRM X |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VIOL Co., Ltd. C-808, 809, Bundang Technopark C, 744, Pangyo-ro, Bundang-gu Seongnam-si, KR 13510 |
| Contact | Chai Kyoung Woo |
| Correspondent | Jong Hyun Kim GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro, Mapo-gu Seoul, KR 03909 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809502330163 | K213612 | 000 |
| 08809502330156 | K213612 | 000 |
| 08809502330149 | K213612 | 000 |