Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) +1 more…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221815

Identifiers

510(k) Number: K221815 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) FDA 510(k)
Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) +1 more… by Baisheng Medical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K221815	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Baisheng Medical Co., Ltd.

Sources (1)

FDA 510(k) K221815 24 fields · synced Jun 19, 2026