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EHL-Probe P70450FST

by Walz Elektronik GmbH

Ref P70450FST

EHL-Probe P70450FST is a device classified as Class IIa in the EU and Class II in the US made by Walz Elektronik GmbH, cleared under FDA 510(k) K230488 on 31 Aug 2023, registered in EUDAMED on 30 Jan 2022 (Basic UDI-DI 426066754EHL-PROBE6M) and listed in FDA GUDID since 25 Oct 2023 (UDI-DI 04260667540219), active as of 25 Oct 2026.

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

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230488

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260667540219 UDI-DI Date25 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230488 Date31 Aug 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number426066754EHL-PROBE6M Basic UDI-DI 04260667540219UDI-DIDate30 Jan 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K230488 decided 31 Aug 2023 Active
  • EUDAMED Basic UDI-DI 426066754EHL-PROBE6M registered 30 Jan 2022 Active
  • FDA GUDID UDI-DI 04260667540219 listed 25 Oct 2023 Listed

Timeline

3 dated events

  1. Registered EUDAMED 426066754EHL-PROBE6M
  2. Cleared FDA 510(k) K230488
  3. Listed FDA GUDID 04260667540219

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  • Withdrawn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
EHL-Probe
Generic name
Electrohydraulic lithotripsy system
Model / reference
P70450FST
Primary DI / UDI-DI
04260667540219
Basic UDI-DI
426066754EHL-PROBE6M
Direct marketing DI
04260667540219
510(k) Number
FDA product code
FFK
EMDN code
Z12020385 Endoscopic lithotripsy instruments - consumables
GMDN term
Electrohydraulic lithotripsy system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4480
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Electrohydraulic lithotripsy system

Cleared under the same submission (K230488)

and 1 more cleared under K230488

Similar devices in this category

Other devices filed under ENDOSCOPIC LITHOTRIPSY INSTRUMENTS.

Other devices from Walz Elektronik GmbH

See all devices from Walz Elektronik GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)