Sonicision SCBA: CE/MDR Class IIb, Covidien LP

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0763000B000002976 Basic UDI-DI 10884521592889UDI-DI	Date4 Nov 2026Registered	StatusActive
United States	GUDID listing GUDID	Number10884521592889 UDI-DI	Date22 Aug 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK180149	Date26 Mar 2018Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0763000B000002976 — open Devices and search for it
AccessGUDID record UDI-DI 10884521592889
FDA 510(k) database 510(k) number K180149

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0763000B000002976 registered 4 Nov 2026 Active
FDA 510(k) K180149 decided 26 Mar 2018 Active
FDA GUDID UDI-DI 10884521592889 listed 22 Aug 2018 Listed

Recalls

2 recalls · 1 ongoing · FDA

- Ongoing Z-0332-2022 FDA Class II initiated 12 Nov 2021
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 FDA Class II initiated 23 Jun 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

5 dated events

26 Mar 2018 Cleared FDA 510(k) K180149
22 Aug 2018 Listed FDA GUDID 10884521592889
23 Jun 2021 Recall initiated FDA recalls Z-2240-2021
12 Nov 2021 Recall initiated FDA recalls Z-0332-2022
4 Nov 2026 Registered EUDAMED 0763000B000002976

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Sonicision™ EUDAMED
Sonicision GUDID
Generic name: Soft-tissue ultrasonic surgical system
Device name: Sonicision Reusable Battery Pack
Model / reference: SCBA

Primary DI / UDI-DI: 10884521592889
Basic UDI-DI: 0763000B000002976
Direct marketing DI: 10884521592889
510(k) Number: K180149
FDA product code: LFL
EMDN code: Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term: Soft-tissue ultrasonic surgical system

Device class: Class IIb EUDAMED
U GUDID
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID U

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.