ClearanceBrief
510(k) K171024 ยท FEO Lithotriptor, Ultrasonic

ShockPulse-SE Lithotripsy System

ApplicantCybersonics, Inc., Erie PA, US
DecisionSubstantially Equivalent, Aug 21, 2017
ReceivedApr 5, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K171024

DateFirm and productCodeLinked 510(k)
Mar 5, 2026Olympus 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		 FEONone listed
Feb 27, 2026Olympus 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		 FEONone listed
Feb 27, 2026Olympus 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		 FEONone listed
Feb 27, 2026Olympus 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		 FEONone listed
Nov 7, 2025Olympus 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		 FEONone listed
Jul 7, 2022Olympus Corporation of the Americas
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Open, Classified		 FEONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.