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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) 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)
Applicant
Baisheng Medical Co., Ltd.
#11, Fusheng Rd., Xinhui District, Jiangmen, Guangdong,
Jiangmen,  CN 529100
Applicant Contact Xi Chen
Correspondent
Baisheng Medical Co., Ltd.
#11, Fusheng Rd., Xinhui District, Jiangmen, Guangdong,
Jiangmen,  CN 529100
Correspondent Contact Sylvia Dong
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/22/2022
Decision Date 11/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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