FDA.reportPublic FDA data

CyberWand USL Ultrasonic Lithotripsy System

Primary DI
H891CWUSLSA4
Brand
CyberWand USL Ultrasonic Lithotripsy System
Company
CYBERSONICS INC
Model
CW-USLSA
Published
2016-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120303000CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMCybersonics, Inc.2012-06-05FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H891CWUSLSA4PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
943561522
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855279005122Lithotripsy Probe, Sterile Single Use ShockPulse-SE, 10.2 Fr (3.40mm) X 396mmSPL-PD3402016-04-30
00855279005009CyberWand Probe SetCW-RBP2016-08-31
00855279005016Lithotripsy System ShockPulse-SE SPL-S2016-04-30
00855279005023Lithotripsy Transducer ShockPulse-SESPL-T2016-04-30
00855279005030Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 11.3 Fr (3.76mm) X 396mmSPL-PD3762016-04-30
00855279005054ShockPulse Lithotripsy GeneratorSPL-G2016-04-30
00855279005061Lithotripsy Footswitch ShockPulse-SESPL-FS2016-04-30
00855279005092Lithotripsy Nose Cone ShockPulse SESPL-NC2016-04-30
00855279005108Lithotripsy Power Cord ShockPulse SESPL-PC2016-04-30
00855279005139Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 5.5 Fr (1.83mm) X 418mmSPL-PD1832016-04-30
00855279005153Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 4.5Fr (1.50mm) X 564mmSPL-PD1502016-04-30
00855279005160Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mmSPL-PD0972016-04-30
00855279005283CyberWand USL NoseCone KitCW-USLNC2016-08-31
00855279005306CyberWand USL Foot SwitchCW-USLFS2016-08-31
00855279005313Cyberwand USL WrenchCW-USLW2016-08-31
00855279005320CyberWand USL Advanced TransducerCW-USLTA2016-08-31
H891CWRBP1CyberWand Probe SetCW-RBP2016-05-23
H891CWRBPBX3CyberWand Probe SetCW-RBP2016-05-23
H891CWUSLFS2CyberWand USL Foot SwitchCW-USLFS2016-05-20
H891CWUSLG2CyberWand USL GeneratorCW-USLG2016-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260667540257EL27-CompactWalz Elektronik GmbHFFK2025-11-12
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210787EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
07613353222413LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311582LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353221836LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311568LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311575LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353176686LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353312046LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353214159LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
04260667540011EL27-CompactWalz Elektronik GmbHFFK2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
07613353187101SWISS DolorClastE.M.S. Electro Medical Systems S.A.FFK2022-10-28
07613353001940LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17