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Sonicision SCBIGA

by Covidien LP

Ref SCBIGA

Sonicision SCBIGA is a device classified as Class I (EU), Unclassified (US) made by Covidien LP, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0763000B00004457Q), cleared under FDA 510(k) K180149 on 26 Mar 2018 and listed in FDA GUDID since 22 Aug 2018 (UDI-DI 10884521592902), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180149

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00004457Q Basic UDI-DI 10884521592902UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521592902 UDI-DI Date22 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180149 Date26 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00004457Q registered 5 Oct 2026 Active
  • FDA 510(k) K180149 decided 26 Mar 2018 Active
  • FDA GUDID UDI-DI 10884521592902 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

  1. Cleared FDA 510(k) K180149
  2. Listed FDA GUDID 10884521592902
  3. Recall initiated FDA recalls Z-2240-2021
  4. Recall initiated FDA recalls Z-0332-2022
  5. Registered EUDAMED 0763000B00004457Q

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SonicisionTM EUDAMED
Sonicision GUDID
Generic name
Surgical instrument battery insertion guide
Device name
Sonicision Battery Insertion Guide
Model / reference
SCBIGA
Primary DI / UDI-DI
10884521592902
Basic UDI-DI
0763000B00004457Q
Direct marketing DI
10884521592902
510(k) Number
FDA product code
LFL
EMDN code
K020280 Devices for surgery with ultrasonic generator, single-use - accessories
GMDN term
Surgical instrument battery insertion guide
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
U

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

Related devices

Category: Surgical instrument battery insertion guide

Cleared under the same submission (K180149)

and 4 more cleared under K180149

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE.

Other devices from Covidien LP

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    Class II

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    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)