Acutron
Acutron is a Class II device made by Ilooda.co., Ltd, cleared under FDA 510(k) K211000 on 9 Jun 2022 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 08800023201444), active as of 31 May 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 | Number08800023201444 | Date27 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211000 | Date9 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 08800023201444
- FDA 510(k) database K211000
Across registries
- FDA 510(k) K211000 decided 9 Jun 2022 Active
- FDA GUDID UDI-DI 08800023201444 listed 27 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K211000
- Listed FDA GUDID 08800023201444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- AcuTron
- Primary DI / UDI-DI
- 08800023201444
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrosurgical system.
- Ultracell 40431 by Beaver-Visitec International Inc
- DIEGO ELITE TS101DC by Gyrus Acmi, Inc.
- POTENZA Tip I-49 by Jeisys Medical Incorporated
- Gyrus ACMI 140034 by Gyrus Acmi, Inc.
- Wet-Field® Eraser® 221268150 by Beaver-Visitec International Inc
- SILKRO by Hironic Co., Ltd.
- Voyant Open Fusion Device EB240 by APPLIED MEDICAL RESOURCES CORP.
- POTENZA Tip P1-08 by Jeisys Medical Incorporated
- Vaporflex® JVHS32030 by Joimax GmbH
- Voyant Maryland Fusion Device with Single-Step Activation EB213 by APPLIED MEDICAL RESOURCES CORP.