ClearanceBrief
Panels › Gastroenterology, Urology › Product code FFK · Class 2

Lithotriptor, Electro-Hydraulic

Regulation 876.4480

0510(k)s in 12 months (61 all time)
0recalls in 12 months (22 all time)
22recalls that name a 510(k)
Get daily alerts for FFKSample briefCSV

Top companies in FFK

Company510(k)sRecalls
Northgate Technologies, Inc.116
Cook Inc.07
Cybersonics, Inc.50
Northgate Research, Inc.50
ACMI CORPORATION04
Electro Medical Systems SA40
Richard Wolf Medical Instruments Corp.40
Boston Scientific Corp21
E.M.S Electro Medical Systems S.A21
Med-Sonics Corp.30
DateFirm and productCodeLinked 510(k)
Apr 13, 2022Northgate Technologies, Inc.
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Terminated		 FFKK130368
Oct 25, 2021Northgate Technologies, Inc.
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragme
Open, Classified		 FFKK130368
Mar 24, 2020Northgate Technologies, Inc.
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary
Terminated		 FFKK914516
Mar 24, 2020Northgate Technologies, Inc.
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Terminated		 FFKK130368
Mar 24, 2020Northgate Technologies, Inc.
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Terminated		 FFKK130368
Jan 31, 2018Cook Inc.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Terminated		 FFKK062475
Jan 31, 2018Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Terminated		 FFKK062475
May 24, 2017Northgate Technologies, Inc.
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fr
Terminated		 FFKK914514
Nov 11, 2009Boston Scientific Corp
Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra
Terminated		 FFKK012445
Aug 9, 2007Gyrus ACMI Corporation
Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transduce
Terminated		 FFKK052135
Mar 30, 2007E.M.S. - Electro Medical Systems SA
Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
Terminated		 FFKK012445
Jul 20, 2004ACMI CORPORATION
ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
Terminated		 FFKK980492
Jul 20, 2004ACMI CORPORATION
ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM
Terminated		 FFKK980492
Jul 20, 2004ACMI CORPORATION
ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM
Terminated		 FFKK980492
Jul 20, 2004ACMI CORPORATION
ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
Terminated		 FFKK980492
Jul 20, 2004Richard Wolf Medical Instrument Corp
Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instrum
Terminated		 FFKK011065
Oct 31, 2003Electro Medical Systems (EMS SA)
LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyo
Terminated		 FFKK012445

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.