Electrosurgical Pads
FDA 510(k) K251235 · Baisheng Medical Co., Ltd.
510(k) numberK251235
Submission
- Device name
- Electrosurgical Pads
- Applicant
- Baisheng Medical Co., Ltd.
Jiangmen, CN - Received
- April 22, 2025
- Decision date
- June 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K250841 | Electrotherapy ElectrodesGXY · Traditional | 08/13/2025SE |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm…GEI · Traditional | 01/08/2024SE |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical…GEI · Traditional | 11/23/2022SE |
| K162034 | OBS Electrosurgical Generator (Model: OBS-350A)GEI · Traditional | 01/30/2017SE |
Questions and answers
When was Electrosurgical Pads cleared by the FDA?
Electrosurgical Pads (K251235) received a 510(k) decision of Substantially Equivalent on June 19, 2025, 58 days after the submission was received.
What is the product code of K251235?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.