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Gyrus ACMI SPL-W

by Gyrus Acmi, Inc.

Ref SPL-W

Gyrus ACMI SPL-W is a device classified as Class I in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 08219250000155), cleared under FDA 510(k) K171024 on 21 Aug 2017 and listed in FDA GUDID since 14 Sep 2018 (UDI-DI 00821925039445), active as of 24 Oct 2026. 6 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

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171024

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 Number08219250000155 Basic UDI-DI 00821925039445UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925039445 UDI-DI Date14 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171024 Date21 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08219250000155 registered 22 Jul 2026 Active
  • FDA 510(k) K171024 decided 21 Aug 2017 Active
  • FDA GUDID UDI-DI 00821925039445 listed 14 Sep 2018 Listed

Recalls

6 recalls · 6 ongoing · FDA

    • Ongoing Z-1494-2026 FDA Class II initiated 8 Jan 2026

    Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

  • 3 recalls, same reason

    • Ongoing Z-1478-2026 FDA Class II initiated 14 Nov 2025
    • Ongoing Z-1479-2026 FDA Class II initiated 14 Nov 2025
    • Ongoing Z-1477-2026 FDA Class II initiated 14 Nov 2025

    Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

    • Ongoing Z-0452-2026 FDA Class II initiated 8 Oct 2025

    The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

    • Ongoing Z-1514-2022 FDA Class II initiated 7 Jul 2022

    Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment

Timeline

9 dated events

  1. Cleared FDA 510(k) K171024
  2. Listed FDA GUDID 00821925039445
  3. Recall initiated FDA recalls Z-1514-2022
  4. Recall initiated FDA recalls Z-0452-2026
  5. Recall initiated FDA recalls Z-1478-2026
  6. Recall initiated FDA recalls Z-1479-2026
  7. Recall initiated FDA recalls Z-1477-2026
  8. Recall initiated FDA recalls Z-1494-2026
  9. Registered EUDAMED 08219250000155

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
Gyrus ACMI
Generic name
Ultrasonic lithotripsy system handpiece
Device name
ShockPulse lithotripsy accessories (nosecone, wrench, stylet)
Model / reference
SPL-W
Primary DI / UDI-DI
00821925039445
Basic UDI-DI
08219250000155
Direct marketing DI
00821925039445
510(k) Number
FDA product code
FEO
EMDN code
Z12010880 Instruments for ultrasonic surgery - hardware accessories
GMDN term
Ultrasonic lithotripsy system handpiece
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.4480
EU registration type
Standard device
EU market of registration
Germany
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
Class II

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

Related devices

Category: Ultrasonic lithotripsy system handpiece

Cleared under the same submission (K171024)

and 4 more cleared under K171024

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)