FDA 510(k)

电外科笔（OBS-Db，OBS-Dr，OBS-Dc，OBS-Df，OBS-Di，OBS-De）；电外科笔（OBS-Dt，OBS-Dd，OBS-Ds，OBS-Dl，OBS-Da）

K号: K221815 · 2022-11-23

决定日期2022-11-23

产品代码GEI

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决定实质等同

器械摘要

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) is the device name listed in this FDA 510(k) record. The listed applicant is Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K221815. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Baisheng Medical Co., Ltd.. The 510(k) number is K221815.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2022-11-23, under 510(k) number K221815.

Who is the listed applicant 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)?

The FDA 510(k) record lists Baisheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is GEI.

列明Baisheng Medical Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250841电疗电极 K251235电外科垫片 K233615电外科垫片（GBS-Dm 1030ac，GBS-Db 1031ac，GBS-Dm 1030a，GBS-Db 1031a，GBS-Dm 1130ac，GBS-Db 1131ac，GBS-Dm 1130a，GBS-Db 1131a，GBS-Dm 1040ac，GBS-Db 1041ac，GBS-Dm 1040a，GBS-Db 1041a，GBS-Dm 1140ac，GBS-Db 1141ac，GBS-Dm 1140a，GBS-Db 1141a，GBS-Db 4030c，GBS-Db 4030，GBS-Db 4040c，GBS-Db 4040，GBS-Dm 1030bc，GBS-Db 1031bc，GBS-Dm 1030b，GBS-Db 1031b，GBS-Dm 1130bc，GBS-Db 1131bc，GBS-Dm 1130b，GBS-Db 1131b，GBS-Dm 1030nc，GBS-Db 1031nc，GBS-Dm 1030n，GBS-Db 1031n，GBS-Dm 1）K162034OBS电外科发生器（型号：OBS-350A）

相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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