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Shockpulse Spl-Sr

by Gyrus Acmi, Inc.

Ref SPL-SR

Shockpulse Spl-Sr is a device classified as Class IIb in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI B-00821925043824), cleared under FDA 510(k) K142428 on 13 Nov 2014 and listed in FDA GUDID since 24 Jul 2024 (UDI-DI 00821925043824), active as of 25 Oct 2026. One FDA recall is 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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142428

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925043824 Basic UDI-DI 00821925043824UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925043824 UDI-DI Date24 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142428 Date13 Nov 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925043824 registered 3 Sep 2026 Active
  • FDA 510(k) K142428 decided 13 Nov 2014 Active
  • FDA GUDID UDI-DI 00821925043824 listed 24 Jul 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-2197-2020 FDA Class II initiated 23 Apr 2020

    A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

Timeline

4 dated events

  1. Cleared FDA 510(k) K142428
  2. Recall initiated FDA recalls Z-2197-2020
  3. Listed FDA GUDID 00821925043824
  4. Registered EUDAMED B-00821925043824

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  • Withdrawn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, reusable
Device name
Spl-Sr
Model / reference
SPL-SR
Primary DI / UDI-DI
00821925043824
Basic UDI-DI
B-00821925043824
510(k) Number
FDA product code
FEO
EMDN code
Z12020302 Ultrasonic endoscopic lithotripters
GMDN term
Ultrasonic lithotripsy system probe, reusable
Device class
Class IIb 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
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00821925043824: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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, reusable

Cleared under the same submission (K142428)

and 2 more cleared under K142428

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

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)