The following data is part of a premarket notification filed by Starmed Co., Ltd. with the FDA for Elra Electrode.
| Device ID | K181758 |
| 510k Number | K181758 |
| Device Name: | ELRA Electrode |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si, KR 10355 |
| Contact | Jun-young Jung |
| Correspondent | Jun-young Jung STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si, KR 10355 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-04-11 |