EHL Probe SCDG - BS

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

EHL Probe SCDG - BS is a Class II device made by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., cleared under FDA 510(k) K243032 on 21 Mar 2025 and listed in FDA GUDID since 26 Jun 2025 (UDI-DI 06973204210794), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06973204210794 UDI-DI	Date26 Jun 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK243032	Date21 Mar 2025Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06973204210794
FDA 510(k) database 510(k) number K243032

Across registries

2 registries list this device

FDA 510(k) K243032 decided 21 Mar 2025 Active
FDA GUDID UDI-DI 06973204210794 listed 26 Jun 2025 Listed

Timeline

2 dated events

21 Mar 2025 Cleared FDA 510(k) K243032
26 Jun 2025 Listed FDA GUDID 06973204210794

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EHL Probe
Generic name: Electrohydraulic lithotripsy system
Model / reference: SCDG - BS

Primary DI / UDI-DI: 06973204210794
510(k) Number: K243032
FDA product code: FFK
GMDN term: Electrohydraulic lithotripsy system

Device class: Class II
Regulation number: 876.4480
GUDID distribution status: In Commercial Distribution

Sterilisation method: Ethylene Oxide
MRI safety: MR Unsafe

Other devices from Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

See all devices from Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. →

Properties

Supplied sterile
Sterilise before use
Single use
Prescription use
Serial number
Expiration date
Manufacturing date

Other properties (8, all answered No)