G1112004
by US Endoscopy
G1112004 is a Class II device made by US Endoscopy, cleared under FDA 510(k) K192265 on 21 May 2020 (2 earlier submissions) and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00724995209155), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00724995209155 | Date23 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192265 | Date21 May 2020 | StatusActive |
Official records
- AccessGUDID record 00724995209155
- FDA 510(k) database K192265
- FDA 510(k) database K172805
- FDA 510(k) database K113265
Across registries
- FDA 510(k) K192265 decided 21 May 2020 Active
- FDA GUDID UDI-DI 00724995209155 listed 23 Apr 2021 Listed
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
Timeline
- Cleared FDA 510(k) K113265
- Cleared FDA 510(k) K172805
- Cleared FDA 510(k) K192265
- Listed FDA GUDID 00724995209155
- Recall initiated FDA recalls Z-0241-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrical-only medical device connection cable, reusable
- Model / Ref / Catalog
- G1112004
- Description
- The GoCart mobile cart is used to store your gi4000 electrosurgery unit for easy transport and and includes two storage baskets with easy roll and lock wheels.
- Primary DI / UDI-DI
- 00724995209155
- FDA product code
- GEI
- GMDN term
- Electrical-only medical device connection cable, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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