FDA.reportPublic FDA data

Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 11.3 Fr (3.76mm) X 396mm

Primary DI
00855279005030
Brand
Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 11.3 Fr (3.76mm) X 396mm
Company
CYBERSONICS INC
Model
SPL-PD376
Published
2016-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEOLithotriptor, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142428000Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc.2014-11-13FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855279005037PackageGS13In Commercial Distribution
00855279005030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085527900503710855279005037
00855279005030008552790050308552790050300855279005030

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic lithotripsy system handpieceA hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
943561522
Device count
1
Lot or batch
true
Expiration date on label
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
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
H891CWUSLNC2CyberWand USL NoseCone KitCW-USLNC2016-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043800SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043688ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043695ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043701ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043718ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925044203ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043831ShockPulseGyrus ACMI, LLCFEO2020-03-02
00821925044197ShockPulseGyrus ACMI, LLCFEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
00821925039445Gyrus ACMIGyrus ACMI, LLCFEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03