EHL-Probe

Ref P201400FST, P303000SST, P243000SST, P303000FST, P45600FST

EHL-Probe (P201400FST) 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 04260667540035), active as of 22 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 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number04260667540035 UDI-DI	Date25 Oct 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK230488	Date31 Aug 2023Decided	StatusActive
European Union	CE/MDR EUDAMED	Number426066754EHL-PROBE6M Basic UDI-DI	Date30 Jan 2022Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 426066754EHL-PROBE6M — open Devices and search for it
AccessGUDID record UDI-DI 04260667540059
AccessGUDID record UDI-DI 04260667540158
AccessGUDID record UDI-DI 04260667540134
AccessGUDID record UDI-DI 04260667540172
FDA 510(k) database 510(k) number K230488

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 04260667540035 listed 25 Oct 2023 Listed

Timeline

3 dated events

30 Jan 2022 Registered EUDAMED 426066754EHL-PROBE6M
31 Aug 2023 Cleared FDA 510(k) K230488
25 Oct 2023 Listed FDA GUDID 04260667540035

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name: Electrohydraulic lithotripsy system
Model / reference: P201400FST, P243000SST, P303000FST, P303000SST, P45600FST

Primary DI / UDI-DI: 04260667540035, 04260667540059, 04260667540158, 04260667540134, 04260667540172
Basic UDI-DI: 426066754EHL-PROBE6M
Direct marketing DI: 04260667540035
04260667540134
04260667540059
04260667540158
04260667540172
510(k) Number: K230488
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

Field	EUDAMED	GUDID
Device class	EUDAMED 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.

Manufacturer details

EUDAMED SRN: DE-MF-000006132

Similar devices in this category

Other devices filed under ENDOSCOPIC LITHOTRIPSY INSTRUMENTS.

Other devices from Walz Elektronik GmbH

EL27-Compact Sterile EHL-Probes

Class II
Lithotron EL27-Compact

Class IIb

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (19, all answered No)