Panels › Gastroenterology, Urology › Product code FEO · Class 2

Lithotriptor, Ultrasonic

Regulation 876.4480

0510(k)s in 12 months (14 all time)

5recalls in 12 months (7 all time)

7recalls that name a 510(k)

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Top companies in FEO

Company	510(k)s	Recalls
Olympus Corporation of the Americas	0	7
E.M.S Electro Medical Systems S.A	5	0
Cybersonics, Inc.	2	0
Fibra Sonics, Inc.	2	0
KARL STORZ Endoscopy-America, Inc.	2	0
Cabot Medical Corp.	1	0
Olympus Corp.	1	0
Richard Wolf Medical Instruments Corp.	1	0

Date	Firm and product	Code	Linked 510(k)
Mar 5, 2026	Olympus Corporation of the Americas Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Des Open, Classified	FEO	K171024
Feb 27, 2026	Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electro Open, Classified	FEO	K171024
Feb 27, 2026	Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System Open, Classified	FEO	K171024
Feb 27, 2026	Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System Open, Classified	FEO	K171024
Nov 7, 2025	Olympus Corporation of the Americas Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device c Open, Classified	FEO	K171024
Jul 7, 2022	Olympus Corporation of the Americas ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S Open, Classified	FEO	K171024
Apr 23, 2020	Olympus Corporation of the Americas OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer Terminated	FEO	K142428

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