Cleared Special

K172805 - gi-4000 Electrosurgical Generator

K172805 is an FDA 510(k) clearance for gi-4000 Electrosurgical Generator, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 35-day FDA review.

K172805 · United States Endoscopy Group, Inc. · General & Plastic Surgery device
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Oct 2017
Decision
35d
Days
Class 2
Risk

K172805 is an FDA 510(k) clearance for the gi-4000 Electrosurgical Generator. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172805

510(k) Number K172805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date October 23, 2017
Days to Decision 35 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2263
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K172805.
Bipolar applicator CELON ProCurve V
K172535 · Olympus Winter & Ibe GmbH · Nov 2017
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K171752 · Genicon, Inc. · Oct 2017
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K172023 · VIOL Co., Ltd. · Oct 2017
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K171593 · Inmode MD , Ltd. · Oct 2017
K172805 · gi-4000 Electrosurgical Generator
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