Ellex 6336540
Ellex 6336540 is a Class II device made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K021550 on 9 Aug 2002 (1 earlier submission) and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 09342395000649), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09342395000649 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021550 | Date9 Aug 2002 | StatusActive |
Official records
- AccessGUDID record 09342395000649
- FDA 510(k) database K021550
- FDA 510(k) database K992824
Across registries
- FDA 510(k) K021550 decided 9 Aug 2002 Active
- FDA GUDID UDI-DI 09342395000649 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K992824
- Cleared FDA 510(k) K021550
- Listed FDA GUDID 09342395000649
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ellex
- Generic name
- Foot-switch, electrical
- Model / reference
- 6336540
- Primary DI / UDI-DI
- 09342395000649
- FDA product code
- GEX, HQF
- GMDN term
- Foot-switch, electrical
- Device class
- Class II
- Regulation number
- 878.4810, 886.4390
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Foot-switch, electrical.
- CannulaCRF CRF-C2550 by Cambridge Interventional LLC
- POTENZA 16 by Jeisys Medical Inc.
- ElectrodeCRF CRF-U1530L by Cambridge Interventional LLC
- CONMED C9863 by Conmed Corporation
- 6700-313-002 by Stryker Corp.
- ERBE 20189-353 by Erbe Elektromedizin GmbH
- Footswitch, Muting 201450 by VASCULAR TECHNOLOGY, INCORPORATED
- CODMAN® 901001FPED by Integra LifeSciences Production Corporation
- ArtiSeal Vessel Sealing System - ArtiSeal Generator ASG-1000 by LivsMed Inc.
- Multi-pole Pulmonary Artery RF Ablation Generator PM1001 by Pulnovo Medical (Wuxi) Co., Ltd.