Cleared Traditional

gi-4000 Electrosurgical Generator

K192265 · United States Endoscopy Group, Inc. · General & Plastic Surgery

May 2020

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K192265 is an FDA 510(k) clearance for the gi-4000 Electrosurgical Generator, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 21, 2020, 274 days after receiving the submission on August 21, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K192265 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2019
Decision Date	May 21, 2020
Days to Decision	274 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).