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gi4000

by US Endoscopy 3 variants

gi4000 (G120000D) is a Class II device made by US Endoscopy, cleared under FDA 510(k) K192265 on 21 May 2020 (1 earlier submission) and listed in FDA GUDID since 13 Nov 2023 (UDI-DI 00724995227340), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00724995227340 UDI-DI Date13 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192265 Date21 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192265 decided 21 May 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00724995227340 listed 13 Nov 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-0241-2023 FDA Class II initiated 17 Oct 2022

    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

Timeline

4 dated events

  1. Cleared FDA 510(k) K172805
  2. Cleared FDA 510(k) K192265
  3. Recall initiated FDA recalls Z-0241-2023
  4. Listed FDA GUDID 00724995227340

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Inert gas-enhanced electrosurgical system
Model / Ref / Catalog
gi4000, G120000D
Primary DI / UDI-DI
00724995227340
510(k) Number
FDA product code
GEI, FEQ
GMDN term
Inert gas-enhanced electrosurgical system
Device class
Class II
Regulation number
878.4400, 876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inert gas-enhanced electrosurgical system

Cleared under the same submission (K172805)

Cleared under the same submission (K192265)

and 3 more cleared under K192265

Similar devices

Also classified as Inert gas-enhanced electrosurgical system.

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)