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ArConnect G1120020

by US Endoscopy

ArConnect G1120020 is a Class II device made by US Endoscopy, cleared under FDA 510(k) K192265 on 21 May 2020 and listed in FDA GUDID since 18 Feb 2022 (UDI-DI 00724995180287), active as of 22 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

510(k) K192265

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00724995180287 UDI-DI Date18 Feb 2022ListedStatusListed 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
  • FDA GUDID UDI-DI 00724995180287 listed 18 Feb 2022 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

3 dated events

  1. Cleared FDA 510(k) K192265
  2. Listed FDA GUDID 00724995180287
  3. Recall initiated FDA recalls Z-0241-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ArConnect
Generic name
Electrosurgical return electrode, single-use
Model / Ref / Catalog
G1120020
Primary DI / UDI-DI
00724995180287
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical return electrode, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical return electrode, single-use

Cleared under the same submission (K192265)

and 3 more cleared under K192265

Similar devices in this category

Other devices filed under Electrosurgical return electrode, single-use.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)