Cleared Traditional

Medline Universal Grounding Pad

K212093 · Medline Industries, Inc. · General & Plastic Surgery

Jan 2022

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K212093 is an FDA 510(k) clearance for the Medline Universal Grounding Pad, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on January 14, 2022, 192 days after receiving the submission on July 6, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K212093 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2021
Decision Date	January 14, 2022
Days to Decision	192 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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).