EHL Probe

FDA UDI

Class II (US FDA UDI)

by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Identity

Trade Name: EHL Probe FDA UDI
Generic Name: Electrohydraulic lithotripsy system FDA UDI
Model / Reference: SCDG - CS FDA UDI

Identifiers

Primary DI / UDI-DI: 06973204210800 FDA UDI
510(k) Number: K243032 FDA UDI
FDA Product Code: FFK FDA UDI
GMDN Term: Electrohydraulic lithotripsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4480 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrohydraulic lithotripsy system

EHL Probe by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic lithotripsy system.

EHL-Probe — Walz Elektronik GmbH · Class II
Autolith Uro-Touch — Northgate Technologies Inc. · Class II
EHL-Probe — Walz Elektronik GmbH · Class II
Econolith E3000 — Medispec, Ltd. · Class II
CyberWand — Gyrus Acmi, Inc. · Class II
Autolith Touch — Northgate Technologies Inc. · Class II
EL27-Compact — Walz Elektronik GmbH · Class II
CYBERWAND — Gyrus Acmi, Inc. · Class II

Cleared under the same submission

K243032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Sources (1)

FDA UDI a95c7f5c-30c3-420a-a676-2c87421fa77f 33 fields · synced Jun 8, 2026