The following data is part of a premarket notification filed by Baisheng Medical Co., Ltd. with the FDA for Electrosurgical Pencil (obs-db, Obs-dr, Obs-dc, Obs-df, Obs-di, Obs-de); Electrosurgical Pencil (obs-dt, Obs-dd, Obs-ds, Obs-dl, Obs-da).
| Device ID | K221815 |
| 510k Number | K221815 |
| Device Name: | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Baisheng Medical Co., Ltd. No.11, Fusheng Road, Xinhui District, Jiangmen, Guangdong, Jiangmen, CN 529100 |
| Contact | Xi Chen |
| Correspondent | Sylvia Dong Baisheng Medical Co., Ltd. No.11, Fusheng Road, Xinhui District, Jiangmen, Guangdong, Jiangmen, CN 529100 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-22 |
| Decision Date | 2022-11-23 |