Sonicision SCBA
by Covidien LP
Sonicision SCBA is a device classified as Unclassified made by Covidien LP, cleared under FDA 510(k) K180149 on 26 Mar 2018 and listed in FDA GUDID since 18 Dec 2021 (UDI-DI 10884521781627), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521781627 | Date18 Dec 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180149 | Date26 Mar 2018 | StatusActive |
Official records
- AccessGUDID record 10884521781627
- FDA 510(k) database K180149
Across registries
- FDA 510(k) K180149 decided 26 Mar 2018 Active
- FDA GUDID UDI-DI 10884521781627 listed 18 Dec 2021 Listed
Recalls
-
- Ongoing Z-0332-2022
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
-
- Terminated Z-2240-2021
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
Timeline
- Cleared FDA 510(k) K180149
- Recall initiated FDA recalls Z-2240-2021
- Recall initiated FDA recalls Z-0332-2022
- Listed FDA GUDID 10884521781627
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sonicision
- Generic name
- Soft-tissue ultrasonic surgical system
- Model / reference
- SCBA
- Primary DI / UDI-DI
- 10884521781627
- 510(k) Number
- FDA product code
- LFL
- GMDN term
- Soft-tissue ultrasonic surgical system
- Device class
- U
- GUDID distribution status
- In Commercial Distribution