Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Electrohydraulic Lithotriptor (TCS-B3-II)

K-Number: K242888 · 2025-03-21

ApplicantGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Decision Date2025-03-21
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Electrohydraulic Lithotriptor (TCS-B3-II) is a medical device manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-03-21 under approval number K242888. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrohydraulic Lithotriptor (TCS-B3-II)?

Electrohydraulic Lithotriptor (TCS-B3-II) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K242888.

When was Electrohydraulic Lithotriptor (TCS-B3-II) approved by the FDA?

Electrohydraulic Lithotriptor (TCS-B3-II) received FDA 510(k) clearance on 2025-03-21, under approval number K242888.

What company makes Electrohydraulic Lithotriptor (TCS-B3-II)?

Electrohydraulic Lithotriptor (TCS-B3-II) is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd..

What is the FDA product code for Electrohydraulic Lithotriptor (TCS-B3-II)?

The FDA product code for Electrohydraulic Lithotriptor (TCS-B3-II) is FFK.

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

K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) K253633Holmium Laser Therapeutic Apparatus (HZ-40)

View all 7 devices →

Related Devices (Code: FFK)

K162119UreTron PF Series ProbeMed-Sonics Corp. K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp. K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑