Cleared Traditional

Electrosurgical Pads

K251235 · Baisheng Medical Co., Ltd. · General & Plastic Surgery

Jun 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K251235 is an FDA 510(k) clearance for the Electrosurgical Pads, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Baisheng Medical Co., Ltd. (Jiangmen, CN). The FDA issued a Cleared decision on June 19, 2025, 58 days after receiving the submission on April 22, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K251235 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2025
Decision Date	June 19, 2025
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	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).