FDA.report

510(k) K230488

Device
EL27-Compact; Sterile EHL-Probes
Applicant
Walz Elektronik GmbH
510(k) number
K230488
Product code
FFK
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-31
Date received
2023-02-23
Regulation
876.4480
Classification name
Lithotriptor, Electro-Hydraulic
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Bernd Vollmer
Address
Walddorfer Strasse 40 Rohrdorf DE 72229 72229

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
04260667540219EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbH2023-10-25
04260667540011EL27-CompactWalz Elektronik GmbH2023-10-25

Other 510(k) Records For Product Code FFK

510(k)DeviceApplicantDecision date
K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-03-21
K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-03-21
K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.2021-06-14
K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2019-05-29
K162119UreTron PF Series ProbeMed-Sonics Corp.2016-08-29
K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp.2016-02-23
K132795CYBERWAND STERILE PROBE SETCybersonics, Inc.2013-11-26
K130368AUTOLITH TOUCH; URO TOUCHNorthgate Technologies, Inc.2013-11-15
K123038SWISS LITHOBREAKERE.M.S Electro Medical Systems S.A2013-01-16
K120303CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMCybersonics, Inc.2012-06-05
K111058URETRON MODEL URTMed-Sonics Corp.2012-03-30
K102169CYBERWAND LITHOTRIPTERCybersonics, Inc.2010-08-30
K092033VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTORElmed USA2010-04-30
K072422CYBERWAND STERILE PADS, MODEL: CW-RBPBXCybersonics, Inc.2007-10-24
K062475LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd.2007-05-09