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Shockpulse Spl-PDBX183

by Gyrus Acmi, Inc.

Ref SPL-PDBX183

Shockpulse Spl-PDBX183 is a device classified as Class IIa in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00821925043749), cleared under FDA 510(k) K171024 on 21 Aug 2017 and listed in FDA GUDID since 24 Jul 2024 (UDI-DI 00821925043749), active as of 7 Nov 2026. 6 FDA recalls are linked to it.

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

CE MDD 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925043749 Basic UDI-DI 00821925043749UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925043749 UDI-DI Date24 Jul 2024ListedStatusListed 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 B-00821925043749 registered 6 Nov 2026 Active
  • FDA 510(k) K171024 decided 21 Aug 2017 Active
  • FDA GUDID UDI-DI 00821925043749 listed 24 Jul 2024 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. Recall initiated FDA recalls Z-1514-2022
  3. Listed FDA GUDID 00821925043749
  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 B-00821925043749

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Shockpulse
Generic name
Ultrasonic lithotripsy system probe, single-use
Device name
Spl-PDBX183
Model / reference
SPL-PDBX183
Primary DI / UDI-DI
00821925043749 EUDAMED
00821925044227 GUDID
Basic UDI-DI
B-00821925043749
510(k) Number
FDA product code
FEO
EMDN code
Z12020302 Ultrasonic endoscopic lithotripters
GMDN term
Ultrasonic lithotripsy system probe, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4480
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925043749
GUDID
00821925044227
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925043749; FDA GUDID lists 00821925044227), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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 probe, single-use

Cleared under the same submission (K171024)

and 4 more cleared under K171024

Similar devices in this category

Other devices filed under ENDOSCOPIC LITHOTRIPSY INSTRUMENTS.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)