FDA.reportPublic FDA data

510(k) K202813

Device
URO-TOUCH 9 French Probe
Applicant
Northgate Technologies, Inc.
510(k) number
K202813
Product code
FFK
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-14
Date received
2020-09-24
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

Applicant Contact#

Contact
Todd Gatto
Address
1591 Scottsdale Ct. Elgin IL US 60123 60123

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FFK#

510(k), Device, Applicant table
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
K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH2023-08-31
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