gi-4000 Electrosurgical Generator
by United States Endoscopy Group, Inc. 2 variants
510(k) K192265
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192265 | Date21 May 2020 | StatusActive |
Recalls
-
- Terminated Z-0241-2023
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The gi-4000 Electrosurgical Generator is a device classified under Electrosurgical Cutting and Coagulation Devices (GEI), designed to deliver controlled electrical energy for tissue ablation, coagulation, and cutting during surgical procedures. It integrates multiple modalities—including Argon plasma coagulation, monopolar, and bipolar electrosurgery—into a single, compact unit to facilitate precise thermal therapies in endoscopic applications.
This device is intended for use in clinical settings where flexible endoscopy is performed, such as gastroenterology or general surgery. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure safety and efficacy. The gi-4000 holds FDA 510(k) clearance (K192265) under the General, Plastic Surgery advisory committee and is classified as a Class II – Special Controls device. Storage and handling must comply with manufacturer guidelines to preserve functionality and sterility.
From the manufacturer
Product Overview The gi4000 electrosurgery unit is designed specifically for flexible endoscopy and has Argon, Monopolar, Bipolar and Lavage functions all built into one compact unit.