CyberWand USL Generator

Primary DI
H891CWUSLG2
Brand
CyberWand USL Generator
Company
CYBERSONICS INC
Model
CW-USLG
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
H891CWUSLG2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic/ultrasonic lithotripsy systemAn assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

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
H891CWUSLNC2CyberWand USL NoseCone KitCW-USLNC2016-05-23

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